Early Versus Delayed Pneumococcal Vaccination in HIV

NCT00137605 | Completed Phase 1

• 3 other identifiers: CTN 147Control # 078760File # 9427-C1574-34C
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

Conditions

Pneumococcal Infections

Keywords

HIV; HIV Infections

Outcome Measures

Primary Outcomes (2)

• Number of serotypes to which a response is found

• A response is defined as a doubling in antibody titer at 1 month compared to baseline.

Secondary Outcomes (5)

• Antibody response at 6 months and one year

• Changes in viral load 3 months post immunization

• Adverse events

• Overall incidence of invasive pneumococcal disease

• Incidence of invasive pneumococcal disease between vaccines

Study Arms (4)

Pneumovax/immediate

EXPERIMENTAL

Biological: Pneumovax

Pneumovax/delayed

EXPERIMENTAL

Biological: Pneumovax

Prevnar/immediate

EXPERIMENTAL

Biological: Prevnar

Prevnar/delayed

EXPERIMENTAL

Biological: Prevnar

Interventions

Pneumovax BIOLOGICAL

Pneumovax/delayed; Pneumovax/immediate

Prevnar BIOLOGICAL

Prevnar/delayed; Prevnar/immediate

Eligibility Criteria

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

You may qualify if:

• HIV-positive
• Between 18 and 65 years of age
• Have a CD4 cell count below 200 cells/mm3
• Willing to begin/change antiretroviral therapy
• Willing and able to provide informed consent

You may not qualify if:

• Pregnant or breastfeeding
• Have had previous pneumococcal vaccination
• Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
• Have hypersensitivity to components of either vaccine
• Have acute feverish illness at the time of vaccination
• Have had splenectomy (removal of the spleen)
• Have received treatment with IVIG within the last 6 months

Sponsors & Collaborators

• CIHR Canadian HIV Trials Network: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (14)

Medical Arts Health Research Group

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Downtown IDC

Vancouver, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

Moncton Hospital

Windsor, New Brunswick, Canada

Location

Victoria General

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

London, Ontario, Canada

Location

Sunnybrook

Toronto, Ontario, Canada

Location

Toronto General

Toronto, Ontario, Canada

Location

Metropolitan Hospital

Windsor, Ontario, Canada

Location

Montreal Chest/Royal-Victoria

Montreal, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Centre Hospitalier Universitaire de Laval

Ste-Foy, Quebec, Canada

Location

Related Publications (2)

• Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6.

  PMID: 23535358 RESULT

• Kimby E, Schar S, Pirosa MC, Vanazzi A, Mey UM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Krasniqi F, Voegeli M, Novak U, Zander T, Bersvendsen H, Mamot C, Mingrone W, Stathis A, Dirnhofer S, Hayoz S, Ostenstad B, Zucca E. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840.

  PMID: 39883948 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections; HIV Infections

Interventions

Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; 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

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Walter Schlech, MD

  Victoria General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: September 1, 2004
• Study Completion: October 1, 2007
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

CA (14)