Evaluation of vaccine response to 13-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine in patients living with HIV/AIDS

Analysis of humoral and cellular immune responses to 13-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine in patients living with HIV/AIDS

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-3wshg2m

Enrollment

Unknown

Registered

2023-06-29

Start date

2023-04-28

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Long-Term Survivors

Interventions

This is a prospective, longitudinal cohort study to assess the humoral and cellular immune response in patients infected with the Human Immunodeficiency Virus (HIV) in the initial and chronic stages w

and Pneumococcal polysaccharide vaccine 23 valent (PPV-23) which presents purified capsular polysaccharides from Streptococcus pneumoniae containing the serotypes: 1, 2, 3, 4, 5, 6, 6B, 7F, 8, 9N, 9V,

E02.095.465.425.400.530.890

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: HIV-infected patients confirmed by confirmatory tests (Western-Blott and/or HIV polymerase chain reaction viral load) who are of any gender identity. Being in regular use of highly effective antiretroviral, according to the definitions of the Ministry of Health, for at least four weeks. Minimum age 18 years old. Signature of the Free and Informed Consent Form (Appendix A) . For the control group: negative quick test for HIV

Exclusion criteria

Exclusion criteria: Patient with a history of anaphylactic reaction to pneumococcal conjugate vaccines (PCV-7, PCV-10 or PCV-13) or 23-valent pneumococcal polysaccharide vacines. Previous vaccination with PCV-7, PCV-10, PCV-13 (interference in the evaluation of the pre-vaccination humoral immune response). Have been vaccinated with PPV-23 less than 1 year ago. Transfusion of blood components or Immunoglobulins in the last 28 days before vaccination with PCV-13 or PPV-23. Blood dyscrasias that prevent intramuscular vaccine application; Fever in the last 24 hours before vaccination

Design outcomes

Primary

Measure	Time frame
It is expected to find in the group with chronic immunoactivation by the human immunodeficiency virus (HIV) a concentration of pneumococcal IgG antibodies approximately between 20-30% below what will be found in the group without chronic immunoactivation and in the non-HIV group, according to the methodology antibody titration using the enzyme immunoassay (ELISA) method standardized by the World Health Organization.	—

Measure

Time frame

It is expected to find in the group with chronic immunoactivation by the human immunodeficiency virus (HIV) a concentration of pneumococcal IgG antibodies approximately between 20-30% below what will be found in the group without chronic immunoactivation and in the non-HIV group, according to the methodology antibody titration using the enzyme immunoassay (ELISA) method standardized by the World Health Organization.

—

Secondary

Measure	Time frame
Secondary outcomes are not expected.	—

Countries

Brazil

Contacts

Public ContactNajara Nascimento

Laboratório de Investigação Médica 56 da Faculdade de Medicina da Universidade de São Paulo

najara.ataide@usp.br+55-11-24987323

Outcome results

None listed

Source: REBEC (via WHO ICTRP)