Trial · NCT00287469
A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
NCT00287469, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2019-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal. Trials, record NCT00287469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00287469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
- NCT number
- NCT00287469
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Hepatitis
- Interventions
- Hepatitis E vaccine, recombinant (Sar 56 kDa), Placebo
- First posted
- 2006-02-06
- Last updated
- 2019-05-29
- Results first posted
- 2019-05-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 14 days after dose 3 at 6 months | Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period. * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of Participants = n x 100 / N |
| Secondary | Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period | 14 days after dose 2 until 14 days after dose 3 | Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of participants = n x 100 / N |
| Secondary | Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases | before dose 1 thru 14 days after dose 3 | Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 14 days after dose 3 at 6 months | Percent of Participants | NUMBER | |
| SECONDARY | Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period | 14 days after dose 2 until 14 days after dose 3 | Percent of Participants | NUMBER | |
| SECONDARY | Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases | before dose 1 thru 14 days after dose 3 | Number of Hepatitis E Cases | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 20mcg Recombinant HEV | Jaundice; IgM ≥ 100 WR U/mL | 0.0 | 95% Confidence Interval 0.0 to 0.4 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | Placebo | Jaundice; IgM ≥ 100 WR U/mL | 6.9 | 95% Confidence Interval 5.3 to 8.8 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 20mcg Recombinant HEV | Jaundice; total lg ≥ 2500 WR U/mL | 0.3 | 95% Confidence Interval 0.1 to 1.0 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | Placebo | Jaundice; total lg ≥ 2500 WR U/mL | 0.1 | 95% Confidence Interval 0.0 to 0.6 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 20mcg Recombinant HEV | Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL | 0.3 | 95% Confidence Interval 0.1 to 1.0 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | Placebo | Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL | 7.0 | 95% Confidence Interval 5.4 to 8.9 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 20mcg Recombinant HEV | Illness; IgM ≥ 100 WR U/mL | 0.0 | 95% Confidence Interval 0.0 to 0.4 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | Placebo | Illness; IgM ≥ 100 WR U/mL | 0.3 | 95% Confidence Interval 0.1 to 1.0 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | 20mcg Recombinant HEV | Illness; total lg ≥ 2500 WR U/mL | 0.0 | 95% Confidence Interval 0.0 to 0.4 | Percent of Participants |
| Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period | Placebo | Illness; total lg ≥ 2500 WR U/mL | 0.0 | 95% Confidence Interval 0.0 to 0.4 | Percent of Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,000 | |
| Overall Study | STARTED | 20mcg Recombinant HEV | 1,000 | |
| Overall Study | COMPLETED | Placebo | 780 | |
| Overall Study | COMPLETED | 20mcg Recombinant HEV | 786 | |
| Overall Study | NOT COMPLETED | Placebo | 220 | |
| Overall Study | NOT COMPLETED | 20mcg Recombinant HEV | 214 |
Source ClinicalTrials.gov
Adverse events546
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 1,000 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | 20mcg Recombinant HEV | 2 | 1,000 | 2 |
| other | Hydrocele | Congenital, familial and genetic disorders | Placebo | 0 | 1,000 | 0 |
| other | Hydrocele | Congenital, familial and genetic disorders | 20mcg Recombinant HEV | 2 | 1,000 | 2 |
| other | Cerumen impaction | Ear and labyrinth disorders | Placebo | 1 | 1,000 | 1 |
| other | Cerumen impaction | Ear and labyrinth disorders | 20mcg Recombinant HEV | 0 | 1,000 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 1,000 | 1 |
| other | Ear pain | Ear and labyrinth disorders | 20mcg Recombinant HEV | 0 | 1,000 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 1,000 | 2 |
| other | Vertigo | Ear and labyrinth disorders | 20mcg Recombinant HEV | 0 | 1,000 | 0 |
1 to 10 of 546Source ClinicalTrials.gov
See all 546 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 1,000 |
| Total, all-cause mortality | 20mcg Recombinant HEV | 6 | 1,000 |
| Total, other adverse events | Placebo | 226 | 1,000 |
| Total, other adverse events | 20mcg Recombinant HEV | 229 | 1,000 |
| Total, serious adverse events | Placebo | 200 | 1,000 |
| Total, serious adverse events | 20mcg Recombinant HEV | 143 | 1,000 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 20mcg Recombinant HEV vs Placebo: deaths from any cause | Trial comparisons |
| 20mcg Recombinant HEV vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00287469
GET https://conductscience.org/api/trials/v1/NCT00287469/results?page=2