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CompletedNCT02094586Updated Jun 28, 2023Results posted

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

A Phase 3 interventional study of PXVX0200 Lot A and PXVX0200 Lot B in Cholera, sponsored by Bavarian Nordic. Completed at 25 sites in 2 countries. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
3,146
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Read the detailed description

The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

02

Conditions studied

  • Cholera

Browse trials for

03

In context

Cholera

83 studies on the registry are indexed under Cholera; 16 are open to participants now.

This study's enrollment of 3,146 is above the median of 262 across 72 interventional studies indexed under Cholera.

Browse Cholera studies →

Lead sponsor

Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.

Browse Bavarian Nordic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy men or women,
  • age 18 to 45 years inclusive;
  • normal medical history and physical examination
  • Women must have a negative pregnancy test.

Exclusion criteria

Exclusion Criteria:

  • travel to a cholera endemic area in the previous 5 years;
  • abnormal stool pattern or regular use of laxatives;
  • Currently active unstable or undiagnosed medical conditions
  • current or recent antibiotic use;
  • pregnancy or nursing;
  • Previously received a licensed or cholera vaccine
  • History of cholera or enterotoxigenic E. coli infection
  • History of Guillain-Barré Syndrome
  • Received or plans to receive any other licensed vaccines, except for seasonal influenza
  • Recipient of bone marrow or solid organ transplant
  • (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
  • Use of systemic chemotherapy in the previous 5 years prior to the study
  • any medical condition
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,146 participants (actual)

Study arms

  • Experimental
    PXVX0200 Lot A

    PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

    Biological: PXVX0200 Lot A

  • Experimental
    PXVX0200 Lot B

    PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

    Biological: PXVX0200 Lot B

  • Experimental
    PXVX0200 Lot C

    PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

    Biological: PXVX0200 Lot C

  • Placebo comparator
    Placebo

    Placebo physiological saline

    Biological: Placebo

Interventions

  • BiologicalPXVX0200 Lot A

    Lot P700-1CA03

  • BiologicalPXVX0200 Lot B

    Lot P700-3CA03

  • BiologicalPXVX0200 Lot C

    Lot P700-6BA03

  • BiologicalPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B

    The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.

    Time frame: Day 11

  2. Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C

    The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.

    Time frame: Day 11

  3. Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C

    The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.

    Time frame: Day 11

Secondary outcomes

  1. SVA Seroconversion at Day 11

    Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11

    Time frame: Day 11

  2. SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181

    GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.

    Time frame: Day 1 - 181

  3. SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181

    Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.

    Time frame: Day 1 - 181

  4. Adverse Events

    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever \& vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29.

    Time frame: Day 1 - 29

07

Results

Posted Jul 15, 2021

Participant flow

Participant flow — Overall Study
MilestonePXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlacebo
Started927933935351
Completed848866876331
Not completed79675920

Outcome measures

PrimaryGeometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B

The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.

Time frame:
Day 11
Reported as:
Geometric mean · Geometric Mean Titer
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
Geometric Mean TiterPXVX0200 Lot APXVX0200 Lot B
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B9220 (8219 to 10343)10034 (8942 to 11260)
Statistical analysis
  • PXVX0200 Lot A · Geometric mean ratio: 0.92 · 95% CI 0.78 to 1.08
SecondarySVA Seroconversion at Day 11

Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11

Time frame:
Day 11
Reported as:
Number · % of participants
SVA Seroconversion at Day 11
% of participantsPXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlacebo
SVA Seroconversion at Day 1194 (92 to 96)93 (91 to 94)94 (92 to 95)4 (2 to 7)
SecondarySVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181

GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.

Time frame:
Day 1 - 181
Reported as:
Geometric mean · Titer
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
TiterPXVX0200 (Lot A, B and C)Placebo
SVA GMT at Day 191 (52 to 162)143 (12 to 1728)
SVA GMT at Day 119922 (4306 to 22865)320 (6 to 16216)
SVA GMT at Day 296170 (3798 to 10025)127 (10 to 1623)
SVA GMT at Day 91560 (322 to 975)127 (10 to 1623)
SVA GMT at Day 181386 (211 to 703)53 (8 to 348)
Anti-CT IgG GMT at Day 1445 (405 to 489)951 (296 to 3057)
Anti-CT IgG GMT at Day 111780 (901 to 3517)800 (319 to 2008)
Anti-CT IgG GMT at Day 292007 (1075 to 3748)848 (316 to 2275)
Anti-CT IgG GMT at Day 911276 (771 to 2111)599 (370 to 972)
Anti-CT IgG GMT at Day 1811116 (687 to 1814)528 (329 to 846)
SecondarySVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181

Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.

Time frame:
Day 1 - 181
Reported as:
Number · % of participants
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
% of participantsPXVX0200Placebo
SVA Seroconversion at Day 1191 (71 to 99)0 (0 to 60)
SVA Seroconversion at Day 2996 (80 to 100)0 (0 to 46)
SVA Seroconversion at Day 9169 (48 to 86)0 (0 to 46)
SVA Seroconversion at Day 18150 (30 to 70)0 (0 to 52)
Anti-CT IgG Seroconversion at Day 1142 (23 to 63)0 (0 to 46)
Anti-CT IgG Seroconversion at Day 2946 (27 to 67)0 (0 to 46)
Anti-CT IgG Seroconversion at Day 9142 (23 to 63)0 (0 to 46)
Anti-CT IgG Seroconversion at Day 18135 (17 to 56)0 (0 to 52)
SecondaryAdverse Events

Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever \& vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29.

Time frame:
Day 1 - 29
Reported as:
Number · % of participants
Adverse Events
% of participantsPXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPXVX0200 (Lot A, B and C)Placebo
% of Subjects with any Reactogenicity52.9950.4452.2851.9043.15
% of Subjects with Diarrhea Symptoms4.313.963.363.881.17
% of Subjects with Fever Symptoms0.770.770.330.621.17
% of Subjects with Nausea/Vomiting18.0318.9418.0018.3215.16
% of Subjects with Headache30.0926.4330.2628.9323.62
PrimaryGeometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C

The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.

Time frame:
Day 11
Reported as:
Geometric mean · Geometric Mean Titer
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
Geometric Mean TiterPXVX0200 Lot BPXVX0200 Lot C
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C10034 (8942 to 11260)9827 (8770 to 11012)
Statistical analysis
  • PXVX0200 Lot B · Geometric mean ratio: 1.02 · 95% CI 0.87 to 1.20
PrimaryGeometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C

The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.

Time frame:
Day 11
Reported as:
Geometric mean · Geometric Mean Titer
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
Geometric Mean TiterPXVX0200 Lot APXVX0200 Lot C
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C9220 (8219 to 10343)9827 (8770 to 11012)
Statistical analysis
  • PXVX0200 Lot A · Geometric mean ratio: 0.94 · 95% CI 0.80 to 1.10

Adverse events

Collected over Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PXVX0200 Lot A1/926 (0.1%)7/926 (0.8%)—
PXVX0200 Lot B0/928 (0%)9/928 (1%)—
PXVX0200 Lot C0/935 (0%)4/935 (0.4%)—
All PXVX0200 Lots1/2,789 (0%)20/2,789 (0.7%)290/2,789 (10.4%)
Placebo0/350 (0%)3/350 (0.9%)33/350 (9.4%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventPXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CAll PXVX0200 LotsPlacebo
ColitisGastrointestinal disorders0/9260/9280/9350/27891/350
Kidney InfectionInfections and infestations0/9261/9280/9351/27891/350
TonsillitisInfections and infestations0/9260/9280/9350/27891/350
Post Procedural HaemorrhageInjury, poisoning and procedural complications0/9260/9280/9350/27891/350
AppendicitisInfections and infestations0/9262/9280/9352/27890/350
PyelonephritisInfections and infestations1/9260/9280/9351/27890/350
Ankle FractureInjury, poisoning and procedural complications1/9260/9280/9351/27890/350
Diabetic ketoacidosisMetabolism and nutrition disorders1/9260/9280/9351/27890/350
Thyroid CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/9260/9280/9351/27890/350
ConvulsionNervous system disorders1/9260/9280/9351/27890/350
Most frequent other events
Most frequent other events
EventPXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CAll PXVX0200 LotsPlacebo
HeadacheNervous system disorders———75/278911/350
FatigueGeneral disorders———59/27898/350
Upper Respiratory Tract InfectionInfections and infestations———57/27895/350
Back PainMusculoskeletal and connective tissue disorders———38/27893/350
FlatulenceGastrointestinal disorders———32/27894/350
Abdominal PainGastrointestinal disorders———29/27892/350

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlaceboTotal
Between 18 and 45 years inclusive — <=18 years00000
Between 18 and 45 years inclusive — Between 18 and 65 years9279339353513146
Between 18 and 45 years inclusive — >=65 years00000
Age, Continuous
Age, Continuous(years)PXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlaceboTotal
Mean29.8 ± 7.7829.9 ± 7.5430.2 ± 7.7229.5 ± 7.5429.9 ± 7.76
Sex: Female, Male
Sex: Female, Male(Participants)PXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlaceboTotal
Female5105035141551682
Male4174304211961464
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlaceboTotal
American Indian or Alaska Native552113
Asian132719564
Native Hawaiian or Other Pacific Islander32319
Black or African American222238231115806
White6496266552182148
More than one race202014761
Unknown or Not Reported151511445
Region of Enrollment
Region of Enrollment(Participants)PXVX0200 Lot APXVX0200 Lot BPXVX0200 Lot CPlaceboTotal
United States8098058173002731
Australia11812811851415
08

Study locations

25 sites
  • Coastal Clinical Research
    Mobile, Alabama 36608, United States
  • Clinical Reseach Consortium Arizona
    Phoenix, Arizona 85004, United States
  • Avail Clinical Research
    DeLand, Florida 32720, United States
  • Miami Research Associates
    Miami, Florida 33143, United States
  • Palm Beach Research
    West Palm Beach, Florida 33409, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Johnson County Clin-Trials
    Lenexa, Kansas 66219, United States
  • Heartland Research Associates
    Wichita, Kansas 67207, United States
  • Central Kentucky Research
    Lexington, Kentucky 40509, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Boston University
    Boston, Massachusetts 02218, United States
  • Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • St. Louis University
    Saint Louis, Missouri 63104, United States
  • Clinical Research Consortium Las Vegas
    Las Vegas, Nevada 89119, United States
  • Rochester Clinical Research
    Rochester, New York 14609, United States
  • Lion Research
    Norman, Oklahoma 73069, United States
  • Coastal Carolina Research
    Mount Pleasant, South Carolina 29464, United States
  • Research Across America
    Dallas, Texas 75234, United States
  • Jean Brown Research
    Salt Lake City, Utah 84124, United States
  • QIMR Berghofer Medical Research Institiue
    Herston, Queensland 4006, Australia
  • AUS Trials Pty Ltd
    Sherwood, Queensland 4035, Australia
  • CMAX
    Adelaide, South Australia 5000, Australia
  • Emeritis Research
    Malvern East, Victoria 3145, Australia
  • Nucleus Network
    Melbourne, Victoria 3004, Australia
  • Linear Clinical Research
    Nedlands, Western Australia 6009, Australia
09

References and documents

Publications

  • McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6. PubMed 29317118 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Feb 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2021, 6 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2014
First posted
Mar 24, 2014
Start
May 2014
Primary completionActual
Feb 2015
CompletionActual
Jun 2015
Results first posted
Jul 15, 2021
Last update
Jun 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02094586
Lead sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
Responsible party
Sponsor
First posted
Mar 24, 2014
Start date
May 2014
Primary completion
Feb 2015
Completion
Jun 2015
Results posted
Jul 15, 2021
Last update
Jun 28, 2023

Study contacts

James McCarty, MD
study director · Emergent Travel Health Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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