Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

11 sites in 2 countries.

About this study

Official title: A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine

Conditions

HIV Infections, Pneumococcal Infections

Being tested

13-valent Pneumococcal Conjugate Vaccine (13vPnC), 23-valent Pneumococcal Polysaccharide Vaccine (23vPS), Blood draw

Keywords

vaccine, 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, human immunodeficiency virus

Medical subject headings

HIV Infections, Pneumococcal Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 13-valent Pneumococcal Conjugate Vaccine (13vPnC)Biological

  13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3

• 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)Biological

  23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)

• Blood drawProcedure or surgery

  Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).

• Blood drawProcedure or surgery

  Also called Screening blood draw(s)

  1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants

   GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.

   Measured: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Aug 2009 (estimated)
2. Study startMar 2010
3. Primary completionApr 2013
4. Study completionApr 2013

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for HIV InfectionsStudies of the same condition, open and under way.
• More trials run by PfizerThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.