Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

NCT03838497 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2014GR0014
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts \<350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).

Conditions

Streptococcal Pneumonia; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Opsonophagocytic assay (OPA) titers for PCV13

  OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results

  Outcome measure will be assessed at two points (baseline and 28 ± 7 days after vaccination).

Secondary Outcomes (1)

• Frequency and duration of local and systemic adverse events

  All participants will be followed until 4 weeks after vaccination

Study Arms (2)

HIV-infected subjects with CD4 T-cell counts <350 cells/µL

ACTIVE COMPARATOR

Intervention to be administered: Prevenar13

Biological: Prevenar13

HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL

ACTIVE COMPARATOR

Intervention to be administered: Prevenar13

Biological: Prevenar13

Interventions

Prevenar13 BIOLOGICAL

Prevenar13 for both arms

HIV-infected subjects with CD4 T-cell counts <350 cells/µL; HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL

Eligibility Criteria

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

You may qualify if:

• HIV-infeted subjects who received antiretroviral therapy for ≥ 4 weeks

You may not qualify if:

• a history of pneumococcal infection within the recent five years
• previous pneumococcal vaccination
• current opportunistic infections
• known immunodeficiency other than HIV infection
• coagulation disorders

Sponsors & Collaborators

• Korea University Guro Hospital: lead

MeSH Terms

Conditions

Pneumonia; Acquired Immunodeficiency Syndrome

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: February 12, 2019
• Study Start: April 2, 2015
• Primary Completion: January 31, 2017
• Study Completion: February 28, 2017
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share