Clinical trial NCT00962780: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Pneumococcal Infections
Keywords: vaccine
13-valent pneumococcal conjugate vaccine
23-valent pneumococcal polysaccharide vaccine
human immunodeficiency virus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 303
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
measure: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
measure: 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 Pediatric and Adult Participants
timeFrame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
measure: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
measure: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
measure: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
timeFrame: Within 14 days after 13vPnC Dose 1
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
timeFrame: Within 14 days after 13vPnC Dose 2
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
timeFrame: Within 14 days after 13vPnC Dose 3
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
timeFrame: Within 14 days after 13vPnC Dose 1
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
timeFrame: Within 14 days after 13vPnC Dose 2
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
timeFrame: Within 14 days after 13vPnC Dose 3
Locations:
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Constanta
country: Romania
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Dundee
country: South Africa
facility: Pfizer Investigational Site
state: KwaZulu-Natal
city: Worcester
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Paarl
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015 Jul 17;29(11):1345-54. doi: 10.1097/QAD.0000000000000689.