Staged Phase I/II Hepatitis C Prophylactic Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01436357|
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Biological: AdCh3NSmut1 Biological: MVA-NSmut Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||548 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Staged Phase I/II Study, to Assess Safety, Efficacy and Immunogenicity of a New Hepatitis C Prophylactic Vaccine Based on Sequential Use of AdCh3NSmut1 and MVA-NSmut|
|Actual Study Start Date :||March 6, 2012|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||May 25, 2018|
Experimental: Arm A (Stage I and II)
Receive AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu): 34 (+/-2) subjects Stage I, then 191 (+/-2) subjects at Stage II.
Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose, intramuscularly on day 0.
Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10^8 plaque forming units (pfu) intramuscularly on day 56.
Placebo Comparator: Arm B (Stage I and II)
Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56: 34 (+/-2) subjects Stage I, then 191 (+/-2) subjects at Stage II.
Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.
- Incidence of chronic hepatitis C virus (HCV) infection at 6 months defined by persistent viremia over a period of 6 months after initial detection of primary infection. [ Time Frame: 6 months ]
- Occurrence of clinical safety laboratory adverse events (AEs) assessed at baseline and 1 month following each vaccination, per treatment arm. [ Time Frame: Day 0 to 1 month ]
- Occurrence of severe local and/or systemic solicited reactogenicity signs and symptoms in the 8 days (Day 0-7) after each vaccination, per treatment arm. [ Time Frame: Day 0 to 7 ]
- Occurrence of vaccine-related serious adverse events (SAEs) from the time of first vaccination through the entire study period, per treatment arm. [ Time Frame: Day 0 to 29 months ]
- Frequency of positive cell mediated immune response by treatment group (vaccine vs. placebo) measured by interferon gamma (IFN-gamma) production by T-cells in response to at least one out of the six HCV genotype 1b peptide pools in the vaccine. [ Time Frame: Within 14 days after the last vaccination (Day 56) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436357
|United States, California|
|University of California San Francisco - Tenderloin Clinical Research Center|
|San Francisco, California, United States, 94102-4012|
|UCSF Community Research Center|
|San Francisco, California, United States, 94102|
|Zuckerberg San Francisco General Hospital Unit 5B|
|San Francisco, California, United States, 94110|
|United States, Maryland|
|Johns Hopkins School of Public Health - Wood Clinic|
|Baltimore, Maryland, United States, 21205-2400|
|United States, New Mexico|
|University of New Mexico - Truman Health Services|
|Albuquerque, New Mexico, United States, 87102|