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 - Full Text View

Purpose

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.

Condition	Intervention	Phase
HIV Infections Pneumococcal Infections	Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Procedure: Blood draw	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Pneumococcal Infections

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Immune responses after 2 and 3 doses of 13vPnC as measured by serotype-specific immunoglobulin G (IgG) geometric mean fold rises (GMFRs) in all subjects. [ Time Frame: 1 month after 3 doses of 13vPnC (approx. 3 months) ] [ Designated as safety issue: No ]
Safety of 13vPnC measured by local reactions, systemic events. [ Time Frame: 14 days post-vaccination, doses 1- 3 ] [ Designated as safety issue: Yes ]
Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immune responses after each dose of study vaccine as measured by IgG in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
Immune responses after each dose of study vaccine as measured by IgG in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]

Enrollment:	303
Study Start Date:	March 2010
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart	Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC) 13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3 Other Name: 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) 23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3) Other Name: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Procedure: Blood draw 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). Other Name: Blood draw Procedure: Blood draw 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. Other Name: Screening blood draw(s)

Arms

Assigned Interventions

Experimental: 1

3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart

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

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

Other Name: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

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

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

Other Name: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Procedure: Blood draw

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).

Other Name: Blood draw

Procedure: Blood draw

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.

Other Name: Screening blood draw(s)

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before study vaccination
Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
No previous vaccination with a pneumococcal vaccine
Subject or parent/legal guardian able to complete an electronic diary

Exclusion Criteria:

Acquired immune deficiency syndrome (AIDS) at time of enrollment
Current illicit substance and/or alcohol abuse
History of active chronic viral hepatitis
Previous anaphylactic reaction to a vaccine or vaccine-related component
Serious chronic disorders including metastatic malignancy and end-stage renal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962780

Locations

Romania
Pfizer Investigational Site
Bucuresti, Romania, 021105
Pfizer Investigational Site
Bucuresti, Romania, 030303
Pfizer Investigational Site
Constanta, Romania, 900709
South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2013
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0083
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0122
Pfizer Investigational Site
Soweto, Gauteng, South Africa, 1818
Pfizer Investigational Site
Dundee, KwaZulu-Natal, South Africa, 3000
Pfizer Investigational Site
Worcester, Western Cape, South Africa, 6850
Pfizer Investigational Site
Bloemfontein, South Africa, 9301
Pfizer Investigational Site
Paarl, South Africa, 7626

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00962780 History of Changes
Obsolete Identifiers:	NCT01098370
Other Study ID Numbers:	6115A1-3002, B1851021
Study First Received:	August 18, 2009
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Pneumococcal Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 18, 2013