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

NCT00962780 | Completed Phase 3 Results DMC

• 2 other identifiers: 6115A1-3002B1851021
• Study Type: interventional
• Target: 303
• Locations: 2 countries
• Sites: 11

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.

Conditions

HIV Infections; Pneumococcal Infections

Keywords

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• 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

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

• 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

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

• 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

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

• 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

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

Other Outcomes (14)

• 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

  Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

• 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

  Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants

  Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

Study Arms (1)

1

EXPERIMENTAL

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

Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); Procedure: Blood draw

Interventions

13-valent Pneumococcal Conjugate Vaccine (13vPnC) BIOLOGICAL

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

1

23-valent Pneumococcal Polysaccharide Vaccine (23vPS) BIOLOGICAL

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

1

Blood draw PROCEDURE

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).

1

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Pfizer Investigational Site

Bucharest, 021105, Romania

Location

Pfizer Investigational Site

Bucharest, 030303, Romania

Location

Pfizer Investigational Site

Constanța, 900709, Romania

Location

Pfizer Investigational Site

Johannesburg, Gauteng, 2013, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0083, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0122, South Africa

Location

Pfizer Investigational Site

Soweto, Gauteng, 1818, South Africa

Location

Pfizer Investigational Site

Dundee, KwaZulu-Natal, 3000, South Africa

Location

Pfizer Investigational Site

Worcester, Western Cape, 6850, South Africa

Location

Pfizer Investigational Site

Bloemfontein, 9301, South Africa

Location

Pfizer Investigational Site

Paarl, 7626, South Africa

Location

Related Publications (1)

• 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.

  PMID: 25888646 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

HIV Infections; Pneumococcal Infections; Acquired Immunodeficiency Syndrome

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Blood Specimen Collection

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; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 20, 2009
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2014-11

Locations

ZA (8); RO (3)