Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults

NCT00618605 | Completed Phase 1 DMC

• 3 other identifiers: Ad26.ENVA.01/IPCAVD-00110623Ad26.ENVA.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.

Conditions

HIV Infections

Keywords

HIV Seronegativity; HIV Preventative Vaccine

Outcome Measures

Primary Outcomes (1)

• Local and systemic reactions to injection

  After each injection

Secondary Outcomes (4)

• Humoral immune responses, such as neutralizing and binding antibodies to HIV and Ad26

  Throughout study

• Cell mediated immunity, including T-cell gamma interferon responses and assessment of T-cell responses by flow cytometry

  Throughout study

• Genotyping

  Throughout study

• Stored samples may be used to perform additional assays for further evaluation of immunogenicity and to support standardization and validation of new assays such as epitope mapping, flow cytometry, and/or tetramer analysis.

  After study follow-up

Study Arms (4)

1

EXPERIMENTAL

3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^9 virus particles (VP) given at Days 0, 28, and 168

Biological: Ad26.ENVA.01 HIV-1 vaccine

2

EXPERIMENTAL

3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^10 VP given at Days 0, 28, and 168

Biological: Ad26.ENVA.01 HIV-1 vaccine

3

EXPERIMENTAL

3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^11 VP given at Days 0, 28, and 168

Biological: Ad26.ENVA.01 HIV-1 vaccine

4

EXPERIMENTAL

2 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at a dose to be determined by the safety data from Arms 1, 2 and 3 given at Days 0 and 168

Biological: Ad26.ENVA.01 HIV-1 vaccine

Interventions

Ad26.ENVA.01 HIV-1 vaccine BIOLOGICAL

Recombinant adenovirus serotype 26 HIV-1 vaccine

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health with normal hematological, hepatic and renal functions
• Demonstrated understanding of study
• Willing to receive HIV test results
• HIV-1 and -2 uninfected
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
• Appropriate hemoglobin, white blood cell, lymphocyte, and platelet count values as defined in the study protocol
• Certain laboratory values as defined in the study protocol
• Adequate contraception from at least 21 days prior to study entry through visit 10

You may not qualify if:

• HIV vaccines or placebos in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
• Blood products within 120 days prior to first injection
• Immunoglobulin within 60 days prior to first injection
• Investigational agents within 30 days prior to first injections
• Live attenuated vaccine within 30 days prior to first injection
• Any vaccine not a live attenuated vaccine within 14 days prior to first injection
• Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
• Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
• Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
• Known autoimmune disease
• Known immunodeficiency
• Asthma other than mild and/or well-controlled asthma
• Active syphilis infection. Those fully treated for syphilis over 6 months prior to study entry are not excluded.
• Diabetes mellitus type 1 or 2

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS

Boston, Massachusetts, 02115-6110, United States

Location

Related Publications (5)

• Abbink P, Lemckert AA, Ewald BA, Lynch DM, Denholtz M, Smits S, Holterman L, Damen I, Vogels R, Thorner AR, O'Brien KL, Carville A, Mansfield KG, Goudsmit J, Havenga MJ, Barouch DH. Comparative seroprevalence and immunogenicity of six rare serotype recombinant adenovirus vaccine vectors from subgroups B and D. J Virol. 2007 May;81(9):4654-63. doi: 10.1128/JVI.02696-06. Epub 2007 Feb 28.

  PMID: 17329340 BACKGROUND

• Liniger M, Zuniga A, Naim HY. Use of viral vectors for the development of vaccines. Expert Rev Vaccines. 2007 Apr;6(2):255-66. doi: 10.1586/14760584.6.2.255.

  PMID: 17408374 BACKGROUND

• Roberts DM, Nanda A, Havenga MJ, Abbink P, Lynch DM, Ewald BA, Liu J, Thorner AR, Swanson PE, Gorgone DA, Lifton MA, Lemckert AA, Holterman L, Chen B, Dilraj A, Carville A, Mansfield KG, Goudsmit J, Barouch DH. Hexon-chimaeric adenovirus serotype 5 vectors circumvent pre-existing anti-vector immunity. Nature. 2006 May 11;441(7090):239-43. doi: 10.1038/nature04721. Epub 2006 Apr 16.

  PMID: 16625206 BACKGROUND

• Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, Johnson JA, Kleinjan J, Yanosick KE, Perry J, Zablowsky E, Abbink P, Peter L, Iampietro MJ, Cheung A, Pau MG, Weijtens M, Goudsmit J, Swann E, Wolff M, Loblein H, Dolin R, Barouch DH. First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):240-7. doi: 10.1093/infdis/jis670. Epub 2012 Nov 2.

  PMID: 23125444 DERIVED

• Barouch DH, Liu J, Peter L, Abbink P, Iampietro MJ, Cheung A, Alter G, Chung A, Dugast AS, Frahm N, McElrath MJ, Wenschuh H, Reimer U, Seaman MS, Pau MG, Weijtens M, Goudsmit J, Walsh SR, Dolin R, Baden LR. Characterization of humoral and cellular immune responses elicited by a recombinant adenovirus serotype 26 HIV-1 Env vaccine in healthy adults (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):248-56. doi: 10.1093/infdis/jis671. Epub 2012 Nov 2.

  PMID: 23125443 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lindsey Baden, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Dan Barouch, MD, PhD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• Raphael Dolin, MD

  Brigham and Women's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2015
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)