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1. Single and two-dose typhoid conjugate vaccine safety and immunogenicity in HIV-exposed uninfected and HIV-unexposed uninfected Malawian children

Author

Nginache Nampota-Nkomba, Osward M. Nyirenda, Victoria Mapemba, Rhoda Masonga, Priyanka D. Patel, Theresa Misiri, Felistas Mwakiseghile, Richard Wachepa, John M. Ndaferankhande, Bright Lipenga, Pratiksha Patel, Happy Banda, Jennifer Oshinsky, Marcela F. Pasetti, Robert S. Heyderman, Leslie P. Jamka, Divya Hosangadi, Shrimati Datta, Melita A. Gordon, Kathleen M. Neuzil, and Matthew B. Laurens

Subjects
Typhoid fever, typhoid vaccine, typhoid conjugate vaccine, HIV-exposed uninfected children, safety, immunogenicity, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950
Abstract

Vaccine safety and immunogenicity data in human immunodeficiency virus (HIV)-exposed uninfected (HEU) children are important for decision-making in HIV and typhoid co-endemic countries. In an open-label study, we recruited Malawian HEU and HIV unexposed uninfected (HUU) infants aged 9 – 11 months. HEU participants were randomized to receive Vi-tetanus toxoid conjugate vaccine (Vi-TT) at 9 months, Vi-TT at 15 months, or Vi-TT at 9 and 15 months. HUU participants received Vi-TT at 9 and 15 months. Safety outcomes included solicited and unsolicited adverse events (AE) and serious AEs (SAEs) within 7 days, 28 days, and 6 months of vaccination, respectively. Serum was collected before and at day 28 after each vaccination to measure anti-Vi IgG antibodies by enzyme-linked immunosorbent assay (ELISA). Cohort 1 (66 participants) enrollment began 02 December 2019, and follow-up was terminated before completion due to the COVID-19 pandemic. Cohort 2 (100 participants) enrollment began 25 March 2020. Solicited AEs were mostly mild, with no significant differences between HEU and HUU participants or one- and two-dose groups. All six SAEs were unrelated to vaccination. Anti-Vi geometric mean titers (GMT) increased significantly from 4.1 to 4.6 ELISA units (EU)/mL at baseline to 2572.0 – 4117.6 EU/mL on day 28 post-vaccination, and similarly between HEU and HUU participants for both one- and two-dose schedules. All participants seroconverted (>4-fold increase in GMT) by the final study visit. Our findings of comparable safety and immunogenicity of Vi-TT in HUU and HEU children support country introductions with single-dose Vi-TT in HIV-endemic countries.

Published
2024
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2. Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial

Author

David S Lawrence, Charles Muthoga, David B Meya, Lillian Tugume, Darlisha Williams, Radha Rajasingham, David R Boulware, Henry C Mwandumba, Melanie Moyo, Eltas N Dziwani, Hendramoorthy Maheswaran, Cecilia Kanyama, Mina C Hosseinipour, Chimwemwe Chawinga, Graeme Meintjes, Charlotte Schutz, Kyla Comins, Funeka Bango, Conrad Muzoora, Samuel Jjunju, Edwin Nuwagira, Mosepele Mosepele, Tshepo Leeme, Chiratidzo E Ndhlovu, Admire Hlupeni, Shepherd Shamu, Timothée Boyer-Chammard, Síle F Molloy, Nabila Youssouf, Tao Chen, Tinevimbo Shiri, Shabbar Jaffar, Thomas S Harrison, Joseph N Jarvis, Louis W Niessen, Jack Goodall, Kwana Lechiile, Norah Mawoko, Tshepiso Mbangiwa, James Milburn, Refilwe Mmipi, Ponego Ponatshego, Ikanyang Rulaganyang, Kaelo Seatla, Keatlaretse Siamisang, Nametso Tlhako, Katlego Tsholo, Samantha April, Abulele Bekiswa, Linda Boloko, Hloni Bookholane, Thomas Crede, Lee-Ann Davids, Rene Goliath, Siphokazi Hlungulu, Regina Hoffman, Henriette Kyepa, Noma Masina, Deborah Maughan, Trevor Mnguni, Sumaiyya Moosa, Tania Morar, Mkanyiseli Mpalali, Jonathan Naude, Ida Oliphant, Achita Singh, Sumaya Sayed, Leago Sebesho, Muki Shey, Loraine Swanepoel, Madalitso Chasweka, Wezi Chimang'anga, Tipatseni Chimphambano, Ebbie Gondwe, Henry Mzinganjira, Aubrey Kadzilimbile, Steven Kateta, Evelyn Kossam, Christopher Kukacha, Bright Lipenga, John Ndaferankhande, Maureen Ndalama, Reya Shah, Andreas Singini, Katherine Stott, Agness Zambasa, Towera Banda, Tarsizio Chikaonda, Gladys Chitulo, Lorren Chiwoko, Nelecy Chome, Mary Gwin, Timothy Kachitosi, Beauty Kamanga, Mussah Kazembe, Emily Kumwenda, Masida Kumwenda, Chimwemwe Maya, Wilberforce Mhango, Chimwemwe Mphande, Lusungu Msumba, Tapiwa Munthali, Doris Ngoma, Simon Nicholas, Lusayo Simwinga, Anthony Stambuli, Gerald Tegha, Janet Zambezi, Cynthia Ahimbisibwe, Andrew Akampurira, Anamudde Alice, Fiona Cresswell, Jane Gakuru, Enock Kagimu, John Kasibante, Daniel Kiiza, John Kisembo, Richard Kwizera, Florence Kugonza, Eva Laker, Tonny Luggya, Andrew Lule, Abdu Musubire, Rhona Muyise, Carol Olivie Namujju, Jane Francis Ndyetukira, Laura Nsangi, Michael Okirworth, Joshua Rhein, Morris K Rutakingirwa, Alisat Sadiq, Kenneth Ssebambulidde, Kiiza Tadeo, Asmus Tukundane, Leo Atwine, Peter Buzaare, Muganzi Collins, Ninsima Emily, Christine Inyakuwa, Samson Kariisa, James Mwesigye, Simpson Nuwamanya, Ankunda Rodgers, Joan Rukundo, Irene Rwomushana, Mike Ssemusu, Gavin Stead, Kathyrn Boyd, Secrecy Gondo, Prosper Kufa, Edward Makaha, Colombus Moyo, Takudzwa Mtisi, Shepherd Mudzinga, Constantine Mutata, Taddy Mwarumba, Tawanda Zinyandu, Alexandre Alanio, Francoise Dromer, Olivier Lortholary, Aude Sturny-Leclere, Philippa Griffin, Sophia Hafeez, Angela Loyse, and Erik van Widenfelt

Subjects
Malawi, Amphotericin B, Cost-Benefit Analysis, Humans, HIV Infections, General Medicine, Meningitis, Cryptococcal
Abstract

HIV-associated cryptococcal meningitis is a leading cause of AIDS-related mortality. The AMBITION-cm trial showed that a regimen based on a single high dose of liposomal amphotericin B deoxycholate (AmBisome group) was non-inferior to the WHO-recommended treatment of seven daily doses of amphotericin B deoxycholate (control group) and was associated with fewer adverse events. We present a five-country cost-effectiveness analysis.The AMBITION-cm trial enrolled patients with HIV-associated cryptococcal meningitis from eight hospitals in Botswana, Malawi, South Africa, Uganda, and Zimbabwe. Taking a health service perspective, we collected country-specific unit costs and individual resource-use data per participant over the 10-week trial period, calculating mean cost per participant by group, mean cost-difference between groups, and incremental cost-effectiveness ratio per life-year saved. Non-parametric bootstrapping and scenarios analyses were performed including hypothetical real-world resource use. The trial registration number is ISRCTN72509687, and the trial has been completed.The AMBITION-cm trial enrolled 844 participants, and 814 were included in the intention-to-treat analysis (327 from Uganda, 225 from Malawi, 107 from South Africa, 84 from Botswana, and 71 from Zimbabwe) with 407 in each group, between Jan 31, 2018, and Feb 17, 2021. Using Malawi as a representative example, mean total costs per participant were US$1369 (95% CI 1314-1424) in the AmBisome group and $1237 (1181-1293) in the control group. The incremental cost-effectiveness ratio was $128 (59-257) per life-year saved. Excluding study protocol-driven cost, using a real-world toxicity monitoring schedule, the cost per life-year saved reduced to $80 (15-275). Changes in the duration of the hospital stay and antifungal medication cost showed the greatest effect in sensitivity analyses. Results were similar across countries, with the cost per life-year saved in the real-world scenario ranging from $71 in Botswana to $121 in Uganda.The AmBisome regimen was cost-effective at a low incremental cost-effectiveness ratio. The regimen might be even less costly and potentially cost-saving in real-world implementation given the lower drug-related toxicity and the potential for shorter hospital stays.European Developing Countries Clinical Trials Partnership, Swedish International Development Cooperation Agency, Wellcome Trust and Medical Research Council, UKAID Joint Global Health Trials, and the National Institute for Health Research.For the Chichewa, Isixhosa, Luganda, Setswana and Shona translations of the abstract see Supplementary Materials section.

Published
2022
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