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Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults

Primary Purpose

HIV Infections

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

VRC-HIVDNA016-00-VP

VRC-HIVADV014-00-VP

Vaccine placebo

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

At risk for HIV
Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry
Willing to comply with the protocol
Willing to undergo HIV testing and HIV counseling and receive HIV test results
Willing to use acceptable forms of contraception

Exclusion Criteria:

HIV-1 or HIV-2 infected
History of immunodeficiency or autoimmune disease
Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry
Certain abnormal laboratory values
Acute or chronic medical condition considered progressive
Hepatitis B or hepatitis C virus infection or untreated syphilis
Live attenuated vaccine within 30 days prior to study
Planned receipt of investigational product within 30 days after first vaccination
Other medically indicated subunit or killed vaccine within 14 days prior to study entry
Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination
Blood transfusion within 120 days of study entry
Immunoglobulin within 60 days of study entry
Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study
Another investigational HIV vaccine at any time
History of severe local or systemic reactogenicity to vaccines
History of severe allergic reactions
History of recurrent urticaria
Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry
Uncontrolled hypertension
Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.

Placebo vaccine

Outcomes

Primary Outcome Measures

Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events

immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses

Secondary Outcome Measures

Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites

safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus

Full Information

NCT ID

NCT00415649

First Posted

December 21, 2006

Last Updated

October 28, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

International AIDS Vaccine Initiative

1. Study Identification

Unique Protocol Identification Number

NCT00415649

Brief Title

Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults

Official Title

A Phase II, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

International AIDS Vaccine Initiative

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.

Detailed Description

Due to the availability of antiretroviral therapy, AIDS-related deaths have lessened in the United States. However, these therapies are widely inaccessible to the developing world. The need for a safe and affordable vaccine that will prevent HIV infection is of utmost importance. To generate a broadly protective vaccine, it is necessary to develop a multivalent vaccine containing a defined combination of immunogens from the most globally prevalent HIV subtypes. This study will evaluate the safety, tolerability, and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine,VRC-HIVDNA016-00-VP, followed by a multiclade recombinant HIV-1 adenoviral vector vaccine, HIVADV014-00-VP. This study will last about 27 months. Participants will be randomly assigned to one of two groups. Group A will receive the DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6; Group B will receive placebo. There will be 20 study visits over 2 years. Physical exams, vital signs measurements, adverse event evaluation, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Preventive Vaccine, HIV Seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo vaccine

Intervention Type

Biological

Intervention Name(s)

VRC-HIVDNA016-00-VP

Intervention Type

Biological

Intervention Name(s)

VRC-HIVADV014-00-VP

Intervention Type

Biological

Intervention Name(s)

Vaccine placebo

Intervention Description

Placebo comparator

Primary Outcome Measure Information:

Title

Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events

Time Frame

throughout study

Title

immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses

Time Frame

throughout study

Secondary Outcome Measure Information:

Title

Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites

Time Frame

throughout study

Title

safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus

Time Frame

throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At risk for HIV Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry Willing to comply with the protocol Willing to undergo HIV testing and HIV counseling and receive HIV test results Willing to use acceptable forms of contraception Exclusion Criteria: HIV-1 or HIV-2 infected History of immunodeficiency or autoimmune disease Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry Certain abnormal laboratory values Acute or chronic medical condition considered progressive Hepatitis B or hepatitis C virus infection or untreated syphilis Live attenuated vaccine within 30 days prior to study Planned receipt of investigational product within 30 days after first vaccination Other medically indicated subunit or killed vaccine within 14 days prior to study entry Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination Blood transfusion within 120 days of study entry Immunoglobulin within 60 days of study entry Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study Another investigational HIV vaccine at any time History of severe local or systemic reactogenicity to vaccines History of severe allergic reactions History of recurrent urticaria Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry Uncontrolled hypertension Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pontiano Kaleebu, MD, PhD

Organizational Affiliation

Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

16362986

Citation

Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.

Results Reference

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PubMed Identifier

17109335

Citation

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8. Erratum In: J Infect Dis. 2009 Oct 15;200(8):1352-3.

Results Reference

background

PubMed Identifier

11390574

Citation

Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.

Results Reference

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Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults

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