Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda

NCT01549470 | Completed Phase 1 DMC

• 2 other identifiers: RV 15610468
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, no vaccine prevents HIV infection. This study will test the safety and immune responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (5)

• Local reactogenicity signs and symptoms

  Measured through Week 48 visit

• Systemic reactogenicity signs and symptoms

  Measured through Week 48 visit

• Laboratory measures of safety

  Measured through Week 48 visit

• All adverse experiences and serious adverse experiences

  Measured through Week 48 visit

• HIV-specific cellular immune responses

  As measured by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot) and intracellular cytokine assay using frozen peripheral blood mononuclear cells (PBMCs) and overlapping peptide pools representing the immunogens.

  Measured through Week 48 visit

Secondary Outcomes (4)

• Lymphoproliferative responses

  Measured through Week 48 visit

• Cytotoxic T lymphocyte (CTL) measured by chromium release assays

  Measured through Week 48 visit

• Antibody immune responses as measured by enzyme-linked immunosorbent assay (ELISA)

  Measured through Week 48 visit

• Neutralizing antibody assays

  Measured through Day 70

Study Arms (2)

Study vaccine

EXPERIMENTAL

Participants in this arm will receive a total of three doses of study vaccine: the first dose at Day 0, the second dose at Day 28 (plus or minus 7 days), and the third dose at Day 56 (plus or minus 7 days). Each dose will consist of a 1-mL injection (dose strength 4 mg/mL) and will be administered by IM injection in the deltoid muscle.

Biological: VRC-HIVDNA009-00-VP

Placebo vaccine

PLACEBO COMPARATOR

Participants in this arm will receive a total of three doses of a placebo vaccine: the first dose at Day 0, the second dose at Day 28 (plus or minus 7 days), and the third dose at Day 56 (plus or minus 7 days). Each dose will consist of a 1-mL injection and will be administered by IM injection in the deltoid muscle.

Biological: Placebo vaccine

Interventions

VRC-HIVDNA009-00-VP BIOLOGICAL

Administered as a 4 mg/mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.

Study vaccine

Placebo vaccine BIOLOGICAL

Administered as a 1-mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.

Placebo vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 40 years old
• Available for follow-up for the duration of the study (13 months)
• Satisfactory completion of an Assessment of Understanding prior to enrollment defined as 90% correct with three opportunities to take test. Errors will be reviewed with volunteer after each test.
• Able and willing to sign the informed consent form
• Willing to receive HIV counseling and testing in accordance with Ugandan Ministry of Health Guidelines
• Willing to discuss HIV infection risks and not currently at high-risk of HIV as defined by responses to a standard questionnaire found in the protocol, agree not to engage in high-risk behavior for HIV during the study as defined by protocol, and amenable to risk-reduction counseling
• Willing to permit a home visit after one of two screening visits
• In good general health without clinically significant medical history
• Physical examination and laboratory results without clinically significant findings within 45 days prior to first injection
• Can understand and read English or Luganda
• Within 45 days prior to enrollment, must meet following criteria:
• Hemoglobin greater than 11.0 g/dL for women and 12.5 g/dL for men
• White blood cell (WBC) count: 3,300 to 12,000 cells/mm\^3 (in the absence of clinical or pathological etiology)
• Differential either within institutional normal range or accompanied by site physician approval. More information on this criterion can be found in the protocol.
• Total lymphocyte count greater than 800 cells/mm\^3 (in the absence of clinical or pathological etiology)

You may not qualify if:

• Woman who is breast-feeding
• Has received HIV vaccines in a prior clinical trial
• Has received immunosuppressive or cytotoxic medications within the past 6 months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis
• Has received blood products within 120 days prior to HIV screening
• Has received immunoglobulin within 60 days prior to HIV screening
• Has received live attenuated vaccines within 30 days prior to initial study vaccine administration
• Has received investigational research agents within 30 days prior to initial study vaccine administration
• Has received medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• Is receiving current anti-tuberculosis (TB) prophylaxis or therapy
• History of a serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• History of autoimmune disease or immunodeficiency
• History of asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years or that requires the use of oral or intravenous corticosteroids
• History of diabetes mellitus (type I or II), with the exception of gestational diabetes
• History of thyroid disease including history of thyroidectomy and diagnoses that required medication within the past 12 months
• History of serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years

Sponsors & Collaborators

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

Study Sites (1)

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

Location

Related Publications (1)

• Graham BS. Clinical trials of HIV vaccines. Annu Rev Med. 2002;53:207-21. doi: 10.1146/annurev.med.53.082901.104035.

  PMID: 11818471 BACKGROUND

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

• Fred Wabwire-Mangen, MB ChB, DTM&H, MPH, PhD

  Makerere Univ. Institute of Public Health, Dept. of Epidemiology and Biostatistics

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Completion: March 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

UG (1)