HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

HIV Infections Clinical Trial

Official title:

HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125970
• Other study ID #: HVTN 204
• Secondary ID: 10061
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: January 2010

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Description:

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. Participants in this study will be recruited in North America, South America, and Africa.

Each volunteer will participate in the study for 36 months. Participants will be randomly assigned to one of two groups. Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2. At Month 6, Group 1 participants will receive an injection of the adenoviral vector HIV vaccine. Group 2 participants will receive placebo at study entry and Months 1, 2, and 6. There will be 17 study visits, which will occur at study entry and every 2 weeks thereafter until Day 70; at Month 6 and every 2 weeks thereafter until Day 210; and Months 9.5, 12, 18, 24, 30, and 36. A physical exam, adverse events reporting, HIV and pregnancy prevention counseling, and medication history will occur at each visit. Blood and urine collection will occur at selected visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: January 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• HIV uninfected

• Has access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study

• Willing to receive HIV test results

• Good general health

• Willing to use acceptable forms of contraception

• Completed at least 12 years of schooling (South African participants only)

Exclusion Criteria:

• HIV vaccines in prior HIV vaccine trial

• Immunosuppressive medications within 168 days prior to first study vaccine administration

• Blood products within 120 days prior to first study vaccine administration

• Immunoglobulin within 60 days prior to first study vaccine administration

• Live attenuated vaccines within 30 days prior to first study vaccine administration

• Investigational research agents within 30 days prior to first study vaccine administration

• Subunit or killed vaccines within 14 days prior to first study vaccine administration

• Current tuberculosis prophylaxis or therapy

• Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health

• Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.

• Any job-related responsibility that would interfere with the study

• Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.

• Autoimmune disease or immunodeficiency

• Active syphilis infection

• Unstable asthma

• Diabetes mellitus type 1 or 2

• Thyroid disease requiring treatment

• Serious angioedema within the past 3 years

• Uncontrolled hypertension

• Bleeding disorder

• Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.

• Seizure disorder

• Asplenia

• Mental illness that would interfere with compliance with the protocol

• Other conditions that, in the judgment of the investigator, would interfere with the study

• Pregnant or breastfeeding

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• VRC-HIVDNA016-00-VP
4 mg administered in deltoid
• VRC-HIVADV014-00-VP
1 x 10^10 PU administered in deltoid
• VRC-HIVDNA016-00-VP placebo
1 mL administered at study entry and Months 1 and 2
• VRC-HIVADV014-00-VP placebo
1 mL administered at Month 6

Locations

Country	Name	City	State
Brazil	Projeto Praca Onze/Hesfa Crs	Rio de Janeiro
Brazil	Sao Paulo HVTU - CRT DST/AIDS CRS	San Paulo
Haiti	Les Centres GHESKIO CRS	Port-au-Prince
Jamaica	Epidemiology Research & Training Unit Jamaica MOH CRS	Kingston
South Africa	Emavundleni Desmond Tutu HIV Centre CRS	Cape Town
South Africa	Soweto HVTN CRS	Johannesburg	Gauteng
South Africa	CAPRISA Aurum CRS	Klerksdorp
United States	Project Brave HIV Vaccine CRS	Baltimore	Maryland
United States	Alabama Vaccine CRS	Birmingham	Alabama
United States	Brigham and Women's Hosp. CRS	Boston	Massachusetts
United States	Vanderbilt Vaccine CRS	Nashville	Tennessee
United States	Miriam Hospital's HVTU	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Brazil,  Haiti,  Jamaica,  South Africa, 

References & Publications (4)

Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. Review. — View Citation

Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. Review. — View Citation

Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. Review. — View Citation

Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic adverse reactions		Measured after each injection and for 12 months after the first injection
Primary	Unfractionated IFN-? ELISpot responses to HIV-1 peptide pools as performed by the VRC laboratory		Measured at Day 196
Primary	Unfractionated IFN-? ELISpot responses to HIV-1 peptide pools as performed by the FHCRC laboratory		Measured at Day 210
Primary	CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based intracellular cytokine staining (ICS) assay as performed by the VRC laboratory		Measured at Day 196
Primary	CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based ICS assay as performed by the FHCRC laboratory		Measured at Day 210
Secondary	Humoral immune response to HIV-1 as measured by neutralizing antibody and binding assays		Measured through Month 36
Secondary	Unfractionated IFN-? ELISpot responses to HIV-1 as performed by the FHCRC or the VRC laboratories		Measured at Days 70, 210, and 364
Secondary	CD4 and CD8 T cell responses to HIV-1 as measured by flow cytometry-based ICS assay as performed by the FHCRC or the VRC laboratories		Measured at Days 70, 210, and 364
Secondary	Vaccine-induced HIV-specific T cell responses to individual peptide pools as measured by IFN-? ELISpot and ICS as performed by the FHCRC or the VRC laboratories		Measured through Month 36
Secondary	Cross-clade cellular immune responses to HIV-1 Gag-Pol-Nef peptides from clades A and C as assessed by IFN-? ELISpot and ICS assays as performed by the FHCRC or the VRC laboratories		Measured through Month 36

External Links

•   Click here for more information on HIV preventive vaccines
•   Haga clic aquí para ver información sobre este ensayo clínico en español.