Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults

NCT00249106 | Completed Phase 1 DMC

• 1 other identifier: IAVI C001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Safety of ADVAX

  dose escalation study

  18 months

Secondary Outcomes (1)

• Immunogenicity of ADVAX

  18 months

Study Arms (2)

HIV vaccine

EXPERIMENTAL

dosage escalation of ADVAX

Biological: ADVAX

Placebo

PLACEBO COMPARATOR

Sodium phosphate

Biological: ADVAX

Interventions

ADVAX BIOLOGICAL

Also known as: DNA HIV vaccine

HIV vaccine; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult males and females;
• Age at least 18 years on the day of screening and no greater than 60 years on the day of the first vaccination;
• Available for follow up for the planned duration of the study (screening plus 18 months);
• In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
• Willing to undergo HIV testing and counseling, and receive HIV test results;
• If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination, and willing to undergo urine pregnancy test.
• If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination.

You may not qualify if:

• 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;
• Any acute or chronic medical condition requiring care of a physician (e.g.,, diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation;
• Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, absolute CD4/CD8 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities that are judged by the principal investigator or designee to be not clinically significant may be enrolled.
• Reported high- risk behaviour for HIV infection, defined as:
• Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship) within 6 months before vaccination
• Engaged in sex work for money or drugs within 6 months before vaccination
• Used injection drugs (illicit), or Acquired an STD within 6 months before vaccination ;
• If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
• Receipt of blood transfusion or blood products 6 months prior to vaccination;
• Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of vaccination;
• Participation in another clinical trial of an investigational product currently or within past 12 weeks or expected participation during this study;
• Receipt of another experimental HIV vaccine at any time;
• Infected with HIV-1 or HIV-2 as indicated by ELISA and/or RT-PCR;
• History of severe local or systemic reaction to vaccination or history of severe allergic reactions;
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphillis;

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Aaron Diamond AIDS Research Center: collaborator
• University of Rochester: collaborator

Study Sites (2)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Vasan S, Schlesinger SJ, Huang Y, Hurley A, Lombardo A, Chen Z, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, Sayeed E, Clark L, Dugin D, Schmidt C, Song Y, Seamons L, Dally L, Ho M, Smith C, Markowitz M, Cox J, Gill DK, Gilmour J, Keefer MC, Fast P, Ho DD. Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine. PLoS One. 2010 Jan 25;5(1):e8617. doi: 10.1371/journal.pone.0008617.

  PMID: 20111582 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

delta inulin

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

• David Ho, MD

  Aaron Diamond AIDS Research Center

  PRINCIPAL INVESTIGATOR

• Michael Keefer, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Soe Than, MD

  International AIDS Vaccine Initiative

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: December 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 11, 2013

Record last verified: 2011-09

Locations

US (2)