MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)

Hepatitis C Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857311
• Other study ID #: V520-022
• Secondary ID: 2009_556
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2009
• Last updated: August 11, 2015
• Start date: May 2004
• Est. completion date: May 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2010
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study

Exclusion Criteria:

• Subject weighs less than 110 lbs.

• Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment

• Subject has any history of anaphylaxis or allergy to vaccine components

• Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids Adsorbed (Td)

• Subject has clinical signs suggestive of cirrhosis

• Subject has had a liver biopsy showing bridging fibrosis or cirrhosis

• Subject is HBsAg positive

• Subject has other known chronic liver disease

• Subject has evidence of hepatocellular carcinoma on liver biopsy

• Subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment

• Subject has been vaccinated with a live virus vaccine in the past 30 days

• Subject has been vaccinated with an inactive virus vaccine in the past 14 days

• Female subject is pregnant or breast-feeding, Male subject is planning to impregnate

• Subject has active drug or alcohol abuse

• Subject is at high risk for HIV infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• MRKAd5 HIV-1 gag vaccine (V520)
3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
• Comparator: Placebo
1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
• Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
• MRKAd5 HIV-1 gag vaccine (V520)
3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)	Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site.; Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.	up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs	Yes
Secondary	Number of Participants With Systemic and Laboratory Adverse Events (AE)	Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.	up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs	Yes
Secondary	Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen	Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).; No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious.	Week 30 (4 weeks after boost injection)	No