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

NCT ID: NCT00249106

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-10-31

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.

Detailed Description

This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding will not apply to the assignment of dose levels (low, middle or high).

Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination.

15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

HIV vaccine

dosage escalation of ADVAX

Group Type: EXPERIMENTAL

ADVAX

Intervention Type: BIOLOGICAL

Placebo

Sodium phosphate

Group Type: PLACEBO_COMPARATOR

ADVAX

Intervention Type: BIOLOGICAL

Interventions

ADVAX

Intervention Type: BIOLOGICAL

Other Intervention Names

DNA HIV vaccine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• History of grand-mal epilepsy, or currently taking anti-epileptics;
• In the opinion of the investigator, unlikely to comply with protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aaron Diamond AIDS Research Center

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

International AIDS Vaccine Initiative

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Aaron Diamond AIDS Research Center

Michael Keefer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Soe Than, MD

Role: STUDY_DIRECTOR

International AIDS Vaccine Initiative

Locations

Rockefeller University Hospital

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20111582 (View on PubMed)

Other Identifiers

IAVI C001

Identifier Type: -

Identifier Source: org_study_id