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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Streptococcal Pneumonia Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This single-center, open-label non-randomized clinical trial was conducted at Korea University Guro Hospital from April 2015 to January 2017. Based on the CD4 T-cell counts at the time of study enrollment, HIV-infected subjects aged ≥ 18 years were divided into two groups, group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL).

The primary objective of the study was to demonstrate that the immune responses to PCV13 serotypes in Group 2 (CD4 T-cell counts <350 cells/µL) were not inferior to those in Group 1 (CD4 T-cell counts ≥350 cells/µL) at one month after vaccination. In addition, the safety profiles of PCV13 were compared between two study groups.

HIV-infected subjects aged ≥ 18 years with stable underlying diseases (≥ 4 weeks on HAART) were eligible for this study. All available subjects with low CD4 T-cell counts (<350 cells/µL, group 2) were recruited, and age/visit day-matched controls with high CD4 T-cell counts (≥350 cells/µL, group 1) were enrolled. The exclusion criteria were as follows: 1) a history of pneumococcal infection within the recent five years, 2) previous pneumococcal vaccination, 3) current opportunistic infections, 4) known immunodeficiency other than HIV infection and 5) coagulation disorders.

The study was approved by the ethics committee of Korea University Guro Hospital (IRB No. 2014GR0014) and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Informed consent was taken for all participants before enrollment. Venous blood samples of 10 mL were collected on day 0 and post-vaccination day 28 ± 7.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prevenar13

Biological

Prevenar13 for both arms

Primary outcomes

Opsonophagocytic assay (OPA) titers for PCV13

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

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

Secondary outcomes

Frequency and duration of local and systemic adverse events

Time frame: All participants will be followed until 4 weeks after vaccination

The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults in the Era of Highly Active Antiretroviral Therapy: Analysis Stratified by CD4 T-cell Count

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Feb 12, 2019
Registry last updated: Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed