Vac Anticolerica

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Vac Anticolerica uses


1 INDICATIONS AND USAGE

Vac Anticolerica is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas.

Vac Anticolerica is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vac Anticolerica is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas.


Limitations of Use:


  • The effectiveness of Vac Anticolerica has not been established in persons living in cholera-affected areas. (1.1)
  • The effectiveness of Vac Anticolerica has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a Vac Anticolerica vaccine. (1.1)
  • Vac Anticolerica has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups. (1.1)

1.1 Limitations of Use

The effectiveness of Vac Anticolerica has not been established in persons living in cholera-affected areas.

The effectiveness of Vac Anticolerica has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a Vac Anticolerica vaccine.

Vac Anticolerica has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

2 DOSAGE AND ADMINISTRATION

For oral administration only.

  • For oral administration only.
  • Prepare and administer Vac Anticolerica in a healthcare setting equipped to dispose of medical waste.
  • Prepare Vac Anticolerica by reconstituting the buffer component in 100 milliliters (mL) of purified bottled water; then add the active component (lyophilized V. cholerae CVD 103-HgR). (2.3) After preparation, a single dose of Vac Anticolerica is 100 mL. (3)
  • Instruct recipients to avoid eating or drinking for 60 minutes before or after oral ingestion of Vac Anticolerica. (2.2)
  • Administer Vac Anticolerica a minimum of 10 days before potential exposure to Vac Anticolerica. (2.1)

2.1 Dosage and Schedule

Administer a single oral dose of Vac Anticolerica a minimum of 10 days before potential exposure to Vac Anticolerica.

The safety and effectiveness of revaccination with Vac Anticolerica have not been established.

2.2 Restrictions on Eating and Drinking

Instruct recipients to avoid eating or drinking for 60 minutes before or after oral ingestion of Vac Anticolerica.

2.3 Preparation, Reconstitution and Administration

Prepare and administer Vac Anticolerica in a healthcare setting equipped to dispose of medical waste .

  • Reconstitution should be completed within 15 minutes of removing the carton from the freezer . Locate the 2 packets: the buffer component (Packet 1) and the active component (Packet 2).
  • Pour 100 mL of cold or room temperature (41°F-72°F; 5°C-22°C) purified bottled water into a clean, disposable cup. Do not use tap water, non-purified bottled water, other beverages, or other liquids.
  • Use scissors to cut the top off the buffer component packet.
  • Empty buffer component packet contents into cup. Effervescence will occur.
  • Using a disposable stirrer, stir until the buffer component completely dissolves.
  • Use scissors to cut the top off the active component packet.
  • Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution.
  • Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates. The active component may not dissolve completely.
  • Vac Anticolerica must be consumed within 15 minutes of reconstitution. The recipient should drink the full contents of the cup at once. Some residue may remain in the cup and should be discarded with the cup.

NOTE: If the packets are reconstituted in the improper order, the vaccine must be discarded .

image of the prep, reconstitution and administration of Vac Anticolerica

2.4 Disposal Instructions

Dispose of the cup, packets and stirrer according to standard procedures for medical waste.

Inactivate any spilled vaccine and clean any non-disposable equipment used in the preparation of Vac Anticolerica with 70% isopropyl alcohol or 10% bleach solution.

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3 DOSAGE FORMS AND STRENGTHS

Vac Anticolerica is a suspension for oral administration. Before reconstitution, each dose of Vac Anticolerica is supplied as a foil packet of buffer and an accompanying foil packet of the active component (lyophilized V. cholerae CVD 103-HgR). After reconstitution, a single dose of Vac Anticolerica is 100 milliliters (mL).

Suspension for oral administration supplied as a packet of the buffer component and a packet of the active component (lyophilized V. cholerae CVD 103-HgR). After preparation, a single dose of Vac Anticolerica is 100 mL. (3)

4 CONTRAINDICATIONS

Do not use in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of Vac Anticolerica or to a previous dose of any Vac Anticolerica vaccine .

Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Vac Anticolerica or to a previous dose of any Vac Anticolerica vaccine. (4)

5 WARNINGS AND PRECAUTIONS

  • The safety and effectiveness of Vac Anticolerica have not been established in immunocompromised persons.
  • Vac Anticolerica may be shed in the stool of recipients for at least 7 days. There is a potential for transmission of the vaccine strain to non- vaccinated close contacts (e.g., household contacts). Use caution when considering whether to administer Vac Anticolerica to individuals with immunocompromised close contacts. (5.2)

5.1 Altered Immunocompetence

The safety and effectiveness of Vac Anticolerica have not been established in immunocompromised persons .

5.2 Shedding and Transmission

Vac Anticolerica may be shed in the stool of recipients for at least 7 days. There is a potential for transmission of the vaccine strain to non-vaccinated close contacts (e.g., household contacts) . Use caution when considering whether to administer Vac Anticolerica to individuals with immunocompromised close contacts.

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6 ADVERSE REACTIONS

The most common adverse reactions were tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact PaxVax, Inc. at 1-800-533-5899 or safetyVac Anticolericapaxvax.com, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of Vac Anticolerica was evaluated in four randomized, placebo-controlled, multicenter clinical trials. A total of 3235 adults 18 through 64 years of age received one dose of Vac Anticolerica and 562 received placebo [physiologic saline (N=551) or lactose (N=11)]. Overall, the mean age was 32.5 years; 53.8% of trial participants were female; 67.1% were White, 27.3% were Black or African American, 1.8% were Asian, 1.7% were multiracial, 1.3% were other, 0.6% were American Indian or Alaskan Native and 0.3% were Native Hawaiian or Pacific Islander. There were 9.3% Hispanic or Latino participants.

Solicited Adverse Reactions

Adults 18 through 45 years of age received Vac Anticolerica in a multi-center, double-blind, randomized (8:1), placebo-controlled trial conducted in the United States and Australia (Study 1). The safety analysis set included 2789 Vac Anticolerica recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 1 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of Vac Anticolerica or placebo in Study 1.

Table 1: Rates of Solicited Adverse Reactions Reported in Vac Anticolerica Trial Participants 18 to 45 Years of Age During 7 Days Post-Vaccination

Study 1 Data are derived from Study 1 (NCT02094586).
Vac Anticolerica Placebo (Saline)
Adverse Reaction (N=2789) N represents number of subjects who completed a memory aid. (N=350)
% %

Tiredness


31.3


27.4


Mild


18.7


16.3


Moderate


12.0


9.9


SevereSevere category includes both grade 3 (severe) and grade 4 (potentially life-threatening) adverse events.


0.7


1.2


Headache


28.9


23.6


Mild


18.9


14.6


Moderate


9.6


8.8


Severe


0.5


0.3


Abdominal Pain


18.7


16.9


Mild


12.1


12.0


Moderate


6.2


5.0


Severe


0.4


0.0


Nausea/Vomiting


18.3


15.2


Mild


13.3


11.4


Moderate


4.7


3.8


Severe


0.3


0.0


Lack of Appetite


16.5


16.6


Mild


11.7


12.2


Moderate


4.4


4.4


Severe


0.3


0.0


Diarrhea


3.9


1.2


Mild


2.4


0.9


Moderate


0.7


0.3


Severe


0.84


0.0


Fever


0.6


1.2


Mild


0.2


0.3


Moderate


0.3


0.9


Severe


0.11


0.0


Grading scales are defined as follows:

Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization.

Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock.

Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization.

Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2- 102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = >40.0 °C/104.0 °F.

Serious Adverse Events

In a pooled analysis of the four clinical studies, 0.6% (20/3235) of Vac Anticolerica recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.

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7 DRUG INTERACTIONS

Avoid concomitant administration of Vac Anticolerica with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer Vac Anticolerica to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

Immune responses to Vac Anticolerica may be diminished when Vac Anticolerica is administered concomitantly with chloroquine. Administer Vac Anticolerica at least 10 days before beginning antimalarial prophylaxis with chloroquine. (7.2)

7.1 Food and Drink

Avoid food or drink for 60 minutes before and after vaccine administration.

7.2 Concomitant Vaccines or Medications

Vaccines

No data are available on concomitant administration of Vac Anticolerica with other vaccines.

Antibiotics

Avoid concomitant administration of Vac Anticolerica with systemic antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Do not administer Vac Anticolerica to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

Antimalarial Prophylaxis

Data from a study with a similar product indicate that the immune responses to Vac Anticolerica may be diminished when Vac Anticolerica is administered concomitantly with chloroquine. Administer Vac Anticolerica at least 10 days before beginning antimalarial prophylaxis with chloroquine.

7.3 Immunosuppressive Treatments

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Vac Anticolerica .

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8 USE IN SPECIFIC POPULATIONS

Pregnancy Registry: available at 1-800-533-5899.

8.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vac Anticolerica during pregnancy. To enroll in or obtain information about the registry, please call PaxVax at 1-800-533-5899.

Risk Summary

Vac Anticolerica is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Maternal Vac Anticolerica disease is associated with adverse pregnancy outcomes including fetal death.

Fetal/neonatal adverse reactions

The vaccine strain may be shed in the stool of the vaccinated mother for at least 7 days, with a potential for transmission of the vaccine strain from mother to infant during vaginal delivery.

8.2 Lactation

Risk Summary

Vac Anticolerica is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Vac Anticolerica.

8.4 Pediatric Use

The safety and effectiveness of Vac Anticolerica have not been established in children and adolescents younger than 18 years.

8.5 Geriatric Use

The safety and effectiveness of Vac Anticolerica have not been established in adults 65 years of age or older.

8.6 Immunocompromised Individuals

The safety and effectiveness of Vac Anticolerica have not been established in immunocompromised individuals. The immunologic response to Vac Anticolerica may be diminished in immunocompromised individuals [see Drug Interactions (7.3)].

11 DESCRIPTION

Vac Anticolerica (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. CVD 103-HgR was constructed from the serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of both copies of the ctxA gene, which prevents the synthesis of active Vac Anticolerica toxin (CT). This attenuated strain remains able to synthesize the immunogenic non-toxic B subunit of CT (encoded by the ctxB gene). In addition, a marker was inserted into the hemolysin gene locus (hlyA) to enable differentiation of the vaccine strain from wild type V. cholerae O1.

The vaccine strain is grown in fermentors under controlled conditions in medium containing casamino acids, yeast extract, mineral salts, and an anti-foaming agent. The bacteria are collected by filtration, diafiltered, and concentrated before addition of a stabilization solution containing ascorbic acid (an antioxidant), Hy-Case SF (hydrolyzed casein [a protein derived from cow's milk], a cryoprotectant), sodium chloride (a stabilizer), and sucrose (a cryoprotectant). The stabilized bacteria are lyophilized, milled, and blended with dried lactose (a desiccant and bulking agent). The active component blend is filled into packets.

The buffer component is manufactured by blending together sodium bicarbonate (a gastric acid neutralizer), sodium carbonate (a buffer), ascorbic acid (a buffer and water chlorine neutralizer), and dried lactose (a manufacturing flow aid). The buffer component blend is filled into packets. One buffer component packet and one active component packet are packaged into individual single dose cartons for distribution.

After reconstitution, Vac Anticolerica contains 4 x 108 to 2 x 109 colony forming units (CFU) of live attenuated V. cholerae CVD 103-HgR. The resulting suspension should be slightly cloudy and may contain white particulates. The active and buffer ingredients are shown in Table 2.

Table 2: Vaccine Composition


Ingredient


Quantity/packet


Active Component Packet


V. cholerae CVD 103-HgR


4 x 108 to 2 x 109 CFUCFU=colony forming units.


Sucrose


≤165.37 mgmg=milligrams.


Sodium chloride


≤17.11 mg


Hy-Case SF (hydrolyzed casein)


≤17.11 mg


Ascorbic acid


≤8.55 mg


Dried lactose


≤2.09 gg=grams.


Buffer Component Packet


Sodium bicarbonate


2.16-2.41 g


Sodium carbonate


0.24-0.49 g


Ascorbic acid


1.50-1.80 g


Dried lactose


0.18-0.22 g

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Vac Anticolerica contains live attenuated Vac Anticolerica bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against Vac Anticolerica following receipt of Vac Anticolerica have not been determined. However, rises in serum vibriocidal antibody 10 days after vaccination with Vac Anticolerica were associated with protection in a human challenge study .

12.2 Pharmacodynamics

Shedding of the vaccine strain was evaluated in the first 7 days post-vaccination in a study of 53 healthy adult vaccine recipients (Study 3). Vac Anticolerica was shed in the stools of 11.3% [95% CI 4.3%, 23.0%] of vaccine recipients on any day through 7 days post-vaccination. During the 7 days post-vaccination, the proportion of subjects shedding was highest on day 7 (7.5% [95% CI 2.1%, 18.2%]). The duration of shedding of the vaccine strain is unknown.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Vac Anticolerica has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility.

14 CLINICAL STUDIES

14.1 Efficacy Against V. cholerae Challenge

Study 2 was a randomized, double-blind, saline placebo-controlled V. cholerae challenge study conducted in the US. Subjects 18 through 45 years of age with no prior history of Vac Anticolerica infection or travel to a cholera-endemic area in the previous 5 years were randomized according to a 1:1 ratio to receive one dose of Vac Anticolerica or placebo. In order to identify the subset of subjects to be challenged, an unblinded statistician prepared four randomly ordered lists of subjects per site, one list each for vaccine recipients with blood type O, vaccine recipients with non-O blood types, placebo recipients with blood type O, and placebo recipients with non-O blood types. This was done to maintain a minimum of 60% blood group O subjects in each treatment group. Individuals with type O blood are less likely to be infected with V. cholerae, but are at risk for developing severe Vac Anticolerica if infected. Each site was provided with a blinded version of the four lists specific to its site and advised on the number of subjects from each list to challenge. In the event that a subject was determined to be ineligible for challenge, the site was instructed to select the next subject from the same list as the ineligible subject

The challenges were split into 2 cohorts for 10 day and 3 month challenges. Subjects were admitted to an inpatient unit. Subjects had nothing by mouth from midnight before ingestion of the challenge strain, except for water, and had nothing by mouth for 90 minutes after ingestion of the challenge strain. Approximately 1 minute prior to challenge, subjects ingested 120 mL sodium bicarbonate (NaHCO3) buffer. The oral challenge consisted of 1 x 105 CFU live wild type V. cholerae El Tor Inaba N16961 in 30 mL NaHCO3 buffer at 10 days or 3 months post-vaccination. The co-primary objectives were to demonstrate the efficacy of a single dose of Vac Anticolerica in the prevention of moderate to severe diarrhea following challenge at 10 days and 3 months post-vaccination. Moderate to severe diarrhea was defined as cumulative diarrheal purge ≥ 3 liters (L) within 10 days after challenge. Diarrheal stool was defined as ≥ 2 unformed stools (takes shape of container) collected during a 48 hour period ≥ 200 grams (g) or a single unformed stool ≥ 300 g. Subjects were instructed to collect every stool from the time of challenge until discharge from the inpatient unit. Nursing staff or study personnel inspected all stool, graded the consistency of the stool and calculated the total weight of diarrheal stool per day. Weight of stool was converted to volume using the formula 1 g=1 mL. Vac Anticolerica recipients challenged at 10 days post-vaccination and Vac Anticolerica recipients challenged at 3 months post-vaccination were compared with a pooled group of placebo (saline) recipients challenged at 10 days or 3 months post-vaccination.

Of the 95 Vac Anticolerica recipients, 68 were challenged; 35 were challenged at 10 days post- vaccination and 33 were challenged at 3 months post-vaccination. Of the 102 placebo recipients, 66 were challenged; 33 were challenged at 10 days post-vaccination and 33 at 3 months post- vaccination. Among all randomized subjects, the mean age was 31.0 years. Overall, the mean age of the challenge population was 31.4 years. More males were in the vaccine group (71.6%) compared to the placebo group (54.9%). The majority of randomized subjects were Black (67.5%), 29.4% were White, 0.5% were American Indian/Alaskan Native, 0.5% were Asian, and 2.0% were other. There were 4.6% Hispanic or Latino participants. Overall 50.3% had blood type O. Among subjects selected for either challenge cohort, more males were challenged in the vaccine group (76.5%) compared to the placebo group (57.6%). The majority (70.9%) of the challenge population were Black, 25.4% were White, 0.7% were American Indian/Alaskan Native, 0.7% were Asian, and 2.2% were other. There were 3.7% Hispanic or Latino participants. Overall, 56.0% of challenged subjects had blood type O.

Vaccine efficacy against the occurrence of moderate to severe diarrhea at 10 days post-vaccination was 90.3% [95% CI 62.7%, 100.0%] and at 3 months post-vaccination was 79.5% [95% CI 49.9%, 100.0%] (Table 3).

Table 3: Vaccine Efficacy in the Prevention of Moderate to Severe Diarrhea Following Challenge with V. cholerae O1 El Tor Inaba at 10 Days and 3 Months Post-Vaccination (Intent-to-Treat Population)

Combined Placebo Data are derived from Study 2 (NCT01895855). Combined placebo group comprised of all placebo recipients who were challenged at either 10 days (N=33) or 3 months (N=33) following vaccination.
Vac Anticolerica Vac Anticolerica 10 Day or 3 Month
10 Day Challenge Challenge strain was V. cholerae O1 El Tor Inaba N16961. 3 Month Challenge Challenge
Parameter N=35 N=number of subjects challenged in each group. N=33 N=66

Number of Subjects with


2 (5.7%)


4 (12.1%)


39 (59.1%)


Moderate or Severe


Diarrhea (Attack Rate)Moderate or severe diarrhea (≥ 3 liters of diarrhea) within 10 days after challenge.




Vaccine Efficacy %Vaccine Efficacy=[(Attack Rate in Placebo Group - Attack Rate in Vaccine Group)/Attack Rate in Placebo Group] x 100. Pre-specified criteria for success were that the lower bound of the two-sided 95% confidence interval for vaccine efficacy must be ≥30% in both the 10 Day and 3 Month challenge groups.


90.3%


79.5%


[95% CICI=confidence interval.]


[62.7%, 100.0%]


[49.9%, 100.0%]

14.2 Immunogenicity

Vibriocidal Antibody Against the Vaccine Strain (classical Inaba)

A vibriocidal antibody assay was used to measure serum levels of neutralizing antibodies against the vaccine strain.

Study 2 was a randomized, double-blind, saline placebo-controlled V. cholerae challenge study conducted in adults 18 through 45 years of age. In the subset of subjects challenged in Study 2, 91% [95% CI 82%, 97%] of vaccinees seroconverted prior to challenge and 9% developed moderate to severe Vac Anticolerica following challenge, while 2% of placebo recipients seroconverted prior to challenge and 59% developed moderate to severe Vac Anticolerica following challenge. (Seroconversion was defined as a ≥ 4-fold rise in serum vibriocidal antibody from baseline to 10 days post-vaccination.) Based on the observed association between seroconversion and protection from V. cholerae disease, seroconversion rate at 10 days post-vaccination was used to evaluate response to vaccination in other age groups.

Study 1 was a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in the US and Australia. A total of 3146 subjects 18 through 45 years of age not previously exposed to Vac Anticolerica were randomized 8:1 to receive one dose of Vac Anticolerica or placebo. The mean age was 29.9 years; 45.2% were male; 68.3% were White, 25.6% were Black, 2.0% were Asian, 1.9% were multiracial, 1.4% were other, 0.4% were American Indian/Alaskan Native, and 0.3% were Native Hawaiian/Pacific Islander. There were 10.0% Hispanic or Latino participants.

In this study, the rates of seroconversion were 93.5% [95% CI 92.5%, 94.4%] in vaccine recipients and 4% [95% CI 2%, 7%] in placebo recipients at 10 days post-vaccination.

Study 4 was a randomized, double-blind, placebo-controlled safety and immunogenicity study conducted in the US. A total of 398 subjects 46 through 64 years of age with no prior history of Vac Anticolerica infection or travel to a cholera-endemic area in the previous 5 years were randomized 3:1 to receive one dose of Vac Anticolerica or placebo. Overall, the mean age of the randomized population was 53.8 years; 45.7% were male; 74.9% were White, 21.9% were Black, 1.8% were American Indian/Alaskan Native, 0.5% were Asian, 0.5% were multiracial, 0.3% were Native Hawaiian/Pacific Islander, and 0.3% were other. There were 7.5% Hispanic or Latino participants.

Seroconversion rates at 10 days post-vaccination by classical Inaba vibriocidal antibody among 46 through 64 year old subjects in Study 4 were compared to those in 18 through 45 year old subjects in Study 1. Vac Anticolerica recipients from Study 1 were in the same age group as those in Study 2, the V. cholerae challenge study.

Adults 46 through 64 years were shown to have a non-inferior rate of seroconversion by classical Inaba vibriocidal antibody at 10 days post-vaccination compared to adults 18 through 45 years of age (Table 4).

Table 4: Vibriocidal Antibody Seroconversion Against Classical Inaba V. cholerae Vaccine Strain at 10 Days Post-Vaccination in Adults 46 through 64 Years of Age (Study 4) Compared to Adults 18 through 45 Years of Age (Study 1) [Bridging Analysis Population]

Vac Anticolerica

Seroconversion

Vac Anticolerica %
Study Data are derived from Study 1 (NCT02094586) and Study 4 (NCT02100631). Dose/CFU N N=number of subjects with analyzable samples at Day 1 and Day 11. [95% CI CI=confidence interval. ]

Study 4

(46 through 64 year olds)


1 x 109


291


90.4%

[86.4%, 93.5%]




Study 1

(18 through 45 year olds)


1 x 109


2687


93.5%

[92.5%, 94.4%]




Difference in Seroconversion

RatesSeroconversion is defined as the percentages of subjects who had at least a 4-fold rise in vibriocidal antibody titer at 10 days post-vaccination compared to baseline. Pre-specified non-inferiority criterion was that the lower bound of the two-sided 95% confidence interval on the difference in seroconversion rate (Study 4 minus Study 1) must be greater than -10 percentage points.


-3.1%

[-6.7%, 0.4%]


Vibriocidal Antibody Against Classical Ogawa, El Tor Inaba and El Tor Ogawa

V. cholerae serogroup O1 consists of four major subtypes: classical Inaba, classical Ogawa, El Tor Inaba and El Tor Ogawa. Serum vibriocidal antibody against the three types of V. cholerae not contained in the vaccine, namely classical Ogawa, El Tor Inaba and El Tor Ogawa, was also measured in Study 2 and Study 4. The percentages of vaccine recipients who seroconverted against each of the 4 major biotype/serotypes of V. cholerae serogroup O1 at 10 days post- vaccination (71.4% to 91.4%) are shown in Table 5.

Table 5: Seroconversion Rates 10 Days Post-Vaccination for the Four Major V. cholerae O1 Serogroup Biotypes and Serotypes in Studies 2 and 4 [Immunogenicity Evaluable Population]

Study 2 Data are derived from Study 2 (NCT01895855) and Study 4 (NCT02100631).

(18 through 45 year olds)

Vac Anticolerica

Study 4

(46 through 64 year olds)

Vac Anticolerica

Vac Anticolerica Strain N N=number of subjects with measurements at baseline and 10 days post-vaccination. One subject in Study 2 did not have a Day 11 measurement and was dropped from the analysis. % Seroconversion is defined as the percentages of subjects who had at least a 4-fold rise in vibriocidal antibody titer at 10 days post-vaccination compared to the titer measured at baseline.

[95% CI CI=confidence interval. ]

N %

[95% CI]


Classical InabaVac Anticolerica contains the classical Inaba strain of V. cholerae O1.


93


90.3%

[82.4%, 95.5%]


291


90.4%

[86.4%, 93.5%]


El Tor Inaba


93


91.4%

[83.8%, 96.2%]


290


91.0%

[87.1%, 94.1%]


Classical Ogawa


93


87.1%

[78.5%, 93.2%]


291


73.2%

[67.7%, 78.2%]


El Tor Ogawa


93


89.2%

[81.1%, 94.7%]


290


71.4%

[65.8%, 76.5%]

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Vac Anticolerica is supplied as shown in Table 6. The contents of both packets are reconstituted with purified bottled water, to form one oral dose of the vaccine.

Presentation Carton NDC Number Components

Single dose carton containing two


NDC 70460-001-01


Buffer Component Packet NDC 70460-003-02


packets


Active Component Packet NDC 70460-002-02

16.2 Storage and Handling

Store Vac Anticolerica buffer component and active component packets frozen at -13°F to 5°F (-25°C to -15°C).

Protect from light and moisture.

Packets do not require thawing prior to reconstitution. Packets should not be out of frozen storage for more than 15 minutes prior to reconstitution; when out of frozen storage, packets should not be exposed to temperatures above 80°F (27°C).

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, the health care professional should inform the individual of the following:

  • Advise vaccine recipients to exercise caution regarding food and water consumed in cholera-affected areas, in accordance with the recommendations from the Centers for Disease Control and Prevention for the prevention of Vac Anticolerica in travelers.
  • Educate vaccine recipients regarding the most common adverse reactions occurring within 7 days post-vaccination with Vac Anticolerica (tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea).
  • Inform vaccine recipients that Vac Anticolerica is a live attenuated vaccine and has the potential for transmission of the vaccine strain to close contacts (e.g., household contacts). For at least 14 days following vaccination with Vac Anticolerica, vaccine recipients should wash their hands thoroughly after using the bathroom and before preparing or handling food.
  • Register women who receive Vac Anticolerica while pregnant in the pregnancy registry by calling 1-800-533-5899 .
  • Instruct vaccine recipients to report adverse reactions to their healthcare provider.

Vac Anticolerica is a trademark of PaxVax Bermuda Ltd.

US License No. 2041

Manufactured by: PaxVax Bermuda Ltd.

Distributed by: PaxVax, Inc., 900 Veterans Blvd., Suite 500, Redwood City, CA 94063, USA

Version: June 2016

© 2016 PaxVax. All rights reserved.

Art. No. DSN 102

Package Label - CARTON - Vac Anticolerica Vaccine, Live, Oral Vac Anticolerica

Vac Anticolerica pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Vac Anticolerica available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Vac Anticolerica destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Vac Anticolerica Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Vac Anticolerica pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Vac Anticolerica?

Depending on the reaction of the Vac Anticolerica after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vac Anticolerica not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Vac Anticolerica addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Vac Anticolerica, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Vac Anticolerica consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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