Phase 2
N=548
Staged Phase I/II Hepatitis C Prophylactic Vaccine
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01436357 ↗Enrolled (actual)
548
Serious AEs
11.9%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months — 14; 14 Participants — p=0.317
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AdCh3NSmut1 (Biological); MVA-NSmut (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months |
14; 14 | 0.317 |
| PRIMARY Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After First Vaccination |
70; 48 | 0.029 sig |
| PRIMARY Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After Second Vaccination |
73; 49 | 0.015 sig |
| PRIMARY Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After First Vaccination |
0; 0 | 0.00 sig |
| PRIMARY Occurrence of Vaccine-related Serious Adverse Events (SAEs) From the Time of First Vaccination Through the Entire Study Period |
0; 0 | — |
| PRIMARY Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After Second Vaccination |
2; 0 | 0.499 |
| SECONDARY Number of Participants With Positive Cell Mediated Immune Response |
97; 4 | — |
Summary
A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1 and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned interim analysis of safety and immunogenicity will be conducted. If no safety signal is detected and there is evidence of a measurable immune response to HCV then 472 (+/-4) volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and 2) determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63 months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended observation for subjects becoming viremic in the last month of follow-up).
Eligibility Criteria
Inclusion Criteria
- Comprehension of informed consent. - 18-45 year old men or women with acknowledged active IDU in the past 90 days and have no travel plans that would interfere with ability to meet the study visit schedule. - In good general health as determined by a participating study physician and results within acceptable ranges for clinical laboratory evaluations as detailed in Appendix A. - Negative for antibodies to hepatitis C virus (anti-HCV). - Negative for HCV RNA. - Negative antibodies to HIV. - Negative for HBsAg. - Able and willing (in the Investigator's opinion) to comply with all study requirements. - Willing to allow the investigators access to their medical records. - Willingness to practice continuous effective contraception from the screening visit through 90 days after the last vaccination (males and females). - Among females, a negative pregnancy test within 24 hours prior to vaccination. - Agreement to refrain from blood donation during the course of the study or after the study. - Provide written informed consent prior to initiation of any study procedures. - Willing to provide contact information for study follow-up activities, including the address, name and contact information of three people who can be contacted to facilitate follow-up compliance.
Exclusion Criteria
- The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic device, blood product, or medication) or has received an experimental agent within 30 days prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. - Prior receipt of a recombinant simian or human adenoviral vaccine or MVA vaccine. - Administration of immunoglobulins and/or any blood products within the 90 days preceding the planned administration of the vaccine candidate. - Any confirmed or suspected immunosuppressive or immunodeficient state, including: HIV infection; asplenia; recurrent, severe infections. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (i.e., known hypersensitivity to aminoglycosideantibiotics or to egg proteins). - History of clinically significant contact dermatitis or other significant dermatological conditions such as psoriasis. - Any history of anaphylaxis in reaction to vaccination. - Pregnancy, lactation or willingness/intention to become pregnant during the study. - History of cancer (except for successfully treated basal cell carcinoma of the skin and cervical carcinoma in situ). - History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, or psychosis requiring medication. The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis that is uncontrolled and would interfere with the ability to adhere to the protocol. - Any other serious chronic illness requiring hospital specialist supervision. - Suspected or known current alcohol abuse as defined by a score of 10 or more on the Alcohol Use Disorders Identification Test (AUDIT) C test (a standardized screening tool used to identify hazardous drinkers or those with active alcohol use disorders, including abuse or dependence). - At high risk of HIV infection by the following criteria (adapted from HIV Network for Prevention Trials (HIVNET) behavioral criteria for high risk of HIV): (1) sexually active male who has sex with men (MSM), defined as (i) male who has had anal sex with male sexual partner or partners in the past year or (ii) a male who exchanged sex with male partner(s) for money or drugs in the past year; and (2) female and in a current relationship with a high risk male (active MSM, HIV positive male). - Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the result of the stud
Data sourced from ClinicalTrials.gov (NCT01436357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.