A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT01371175
• Lead Sponsor: International AIDS Vaccine Initiative

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.

Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2005-05
• Study First Submitted: 2011-05-31
• Status Verified: 2011-06
• Study First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Study First Posted: 2011-06-10
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

1. Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
2. Presence of any chronic condition;
3. Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (haemoglobin, absolute neutrophil count absolute lymphocyte count , absolute CD4 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities which are judged by the principal investigator or designee to be not clinically significant may be enrolled.
4. If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
5. Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment;
6. Receipt of blood transfusion or blood products 6 months prior to enrolment;
7. Participation in another clinical trial of an investigational product currently or within last 12 weeks or expected participation during this study;
8. History of severe local or general reaction to vaccination or history of allergic reactions;
9. History of grand-mal epilepsy, or currently taking anti-epileptics;
10. Confirmed HIV-1 or HIV-2 seropositive;
11. Positive for hepatitis B (surface antigen) or confirmed diagnosis of active syphilis at the time of enrolment (RPR positive and TPHA positive or equivalent), positive for hepatitis C antibodies;
12. Unlikely to comply with protocol. Prior receipt of smallpox vaccination should be documented, but will not be an exclusion criterion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)	18 months

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.	Day 0, Month 1, Month 2, Month 5, Month 6, Month 8, Month 9, Month 12, Month 18

Trial Locations

Locations (2)

KAVI (Kenya AIDS Vaccine Initiative); 🇰🇪 Nairobi, Kenya

Guys and St. Thomas' Hospital; 🇬🇧 London, United Kingdom