A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Different Combinations of DNA-HIV-PT123 and AIDSVAX® B/E in Healthy, HIV Uninfected Adult Participants

National Institute of Allergy and Infectious Diseases (NIAID)7 sites in 1 country104 target enrollmentJuly 2014

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 104
Locations: 7
Primary Endpoint: Frequency of serious adverse events (SAEs)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

Detailed Description

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the combination of two different experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-administered in different sequences or simultaneously, in healthy adults who are not infected with HIV. Participants will be randomly assigned to four groups. Depending on which group participants are in, they will receive different combinations of the DNA-HIV-PT123 vaccine, the AIDSVAX® B/E vaccine, a placebo for DNA-HIV-PT123 vaccine, and/or a placebo for AIDSVAX® B/E vaccine. Study visits will occur at study entry, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. All participants will receive their assigned combinations of vaccines at study entry and Months 1, 3, and 6. At each vaccination visit, participants will receive one injection in each upper arm. Following each vaccination, participants will remain in the clinic for 30 minutes for monitoring. All study visits will include a physical examination, HIV risk reduction counseling, and questionnaires and assessments. Select study visits will also include a urine collection, a blood collection, a pregnancy test for participants who were born female, and HIV testing and counseling.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

December 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General and Demographic Criteria
•Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
•Ability and willingness to provide informed consent
•Assessment of understanding: participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly
•Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
•Good general health as shown by medical history, physical exam, and screening laboratory tests
•HIV-Related Criteria:
•Willingness to receive HIV test results
•Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
•Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit

Exclusion Criteria

•Blood products received within 120 days before first vaccination
•Investigational research agents received within 30 days before first vaccination
•Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or known hyperlipidemia
•Intent to participate in another study of an investigational research agent before the last required protocol clinic visit
•Pregnant or breastfeeding
•Vaccines and Other Injections
•HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 105 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis.
•Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by FDA. For participants who have received control/placebo in an experimental vaccine trial, the HVTN 105 PSRT will determine eligibility on a case-by-case basis. For participants who have received an experimental vaccine(s) more than 5 years ago, eligibility for enrollment will be determined by the HVTN 105 PSRT on a case-by-case basis.
•Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
•Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, hepatitis A or B)