Immune Responses to Two Experimental HIV Vaccines in Healthy Adults

NCT01386489 | Completed Phase 1

• 2 other identifiers: 11019711-I-0197
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection. Purpose: The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines. Eligibility: Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements. Design: Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests. The study will have two groups: \<TAB\>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months. \<TAB\>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months. All participants will be asked to provide blood and body fluid samples for testing during the study. Payment for participation will be provided....

Conditions

HIV Negative; Adaptive Immunity; Innate Immunity

Keywords

HIV-uninfected; Mucosal Immunity; Kinetics; Cytokines; Chemokines; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...

Secondary Outcomes (1)

• To assess the safety and tolerability of the investigational vaccines.

Interventions

VRC-HIVDNA016-00-VP BIOLOGICAL

VRC-HIVADV014-00-VP BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A volunteer must meet all of the following criteria:
• to 50 years old.
• No prior vaccinations with an HIV vaccine or adenoviral vector vaccine.
• Available for clinical follow-up for up to 36 weeks after enrollment and committed to follow-up contacts through 144 weeks after enrollment.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Able and willing to complete the informed consent process.
• Willing to donate oral, rectal and genital secretion samples and blood samples for research that will be stored and used for future research.
• Willing to discuss HIV infection risks with the study clinicians, assessed as low risk for HIV infection, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required clinic visit in the protocol schedule.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings and a weight 50 kg or more with body mass index (BMI) less than or equal to 40 within the 56 days prior to enrollment.
• Laboratory Criteria within 56 days prior to enrollment:
• Hemoglobin greater than or equal to 11.2 g/dL for women; greater than or equal to 13.0 g/dL for men.
• White blood cells (WBC) = 3,000-12,000 cells/mm(3).
• Differential and platelet count either within institutional normal range or accompanied by site physician approval.
• Alanine aminotransferase (ALT) less than or equal to 1.75 times upper limit of normal.

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply:
• Woman who is breast-feeding or planning to become pregnant during study participation.
• Woman who is known to not have a cervix or who report having a clinically significant abnormal Pap smear without a subsequent normal result.
• Volunteer has received any of the following substances:
• Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. \[With the exception that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in the study will not exclude study participation.\]
• Blood products or immunoglobulin within 56 days (8 weeks) prior to enrollment.
• Investigational research agents within 28 days (4 weeks) prior to enrollment.
• Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to enrollment.
• Current anti-tuberculosis prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• Clinically significant autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• McElrath MJ, Haynes BF. Induction of immunity to human immunodeficiency virus type-1 by vaccination. Immunity. 2010 Oct 29;33(4):542-54. doi: 10.1016/j.immuni.2010.09.011.

  PMID: 21029964 BACKGROUND

• Borrow P, Shattock RJ, Vyakarnam A; EUROPRISE Working Group. Innate immunity against HIV: a priority target for HIV prevention research. Retrovirology. 2010 Oct 11;7:84. doi: 10.1186/1742-4690-7-84.

  PMID: 20937128 BACKGROUND

• Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.

  PMID: 20126394 BACKGROUND

Study Officials

• Julie E Ledgerwood, D.O.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: June 17, 2011
• Primary Completion: March 9, 2014
• Study Completion: March 19, 2014
• Last Updated: December 16, 2019

Record last verified: 2014-03-19

Locations

US (1)