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Doherty, Klara, Dula, Dingase, Chirwa, Anthony, Nsomba, Edna, Nkhoma, Vitumbiko S., Toto, Neema, Chikaonda, Tarsizio, Kamng'ona, Raphael, Phiri, Joseph, Reiné, Jesús, Ndaferankhande, John, Makhaza, Lumbani, Banda, Peter, Jambo, Kondwani 
ORCID: https://orcid.org/0000-0002-3195-2210, Ferreira, Daniela ORCID: https://orcid.org/0000-0002-0594-0902 and Gordon, Stephen ORCID: https://orcid.org/0000-0001-6576-1116
(2024)
'Experimental pneumococcal carriage in people living with HIV in Malawi: the first controlled human infection model in a key at-risk population'. Wellcome Open Research, Vol 9, Issue 2.
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Abstract
Background:
As well as suffering a high burden of pneumococcal disease people living with HIV (PLHIV) may contribute to community transmission in sub-Saharan African (sSA) settings. Pneumococcal vaccination is not currently offered to PLHIV in sSA but may prevent disease and reduce transmission. More evidence of vaccine effectiveness against carriage in PLHIV is needed. An Experimental Human Pneumococcal Carriage model (EHPC) has been safely and acceptably used in healthy adults in Malawi to evaluate pneumococcal vaccines against carriage and to identify immune correlates of protection from carriage. This study will establish the same model in PLHIV and will be the first controlled human infection model (CHIM) in this key population.
Methods:
Healthy participants with and without HIV will be inoculated intranasally with Streptococcus pneumoniae serotype 6B. Sequential cohorts will be challenged with increasing doses to determine the optimal safe challenge dose to establish experimental carriage. Nasal fluid, nasal mucosal, and blood samples will be taken before inoculation and on days 2, 7, 14, and 21 following inoculation to measure pneumococcal carriage density and identify immune correlates of protection from carriage. The vast majority of natural pneumococcal carriage events in PLHIV do not result in invasive disease and no invasive disease is expected in this study. However, robust participant safety monitoring is designed to identify signs of invasive disease early should they develop, and to implement treatment immediately. Participants will complete a Likert-style questionnaire at study-end to establish acceptability.
Interpretations:
We expect the EHPC model to be safely and acceptably implemented in PLHIV. The CHIM can then be used to accelerate pneumococcal vaccine evaluations in this population, and an evidence-based pneumococcal vaccination policy for PLHIV in sSA.
| Item Type: | Article |
|---|---|
| Subjects: | WC Communicable Diseases > Infection. Bacterial Infections > Bacterial Infections > WC 217 Pneumococcal infections WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department Clinical Sciences & International Health > Malawi-Liverpool-Wellcome Programme (MLW) |
| Digital Object Identifer (DOI): | https://doi.org/10.12688/wellcomeopenres.19949.1 |
| SWORD Depositor: | JISC Pubrouter |
| Depositing User: | JISC Pubrouter |
| Date Deposited: | 12 Feb 2024 13:43 |
| Last Modified: | 12 Feb 2024 13:43 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/23824 |
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