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A malaria control program established in 2004 on Bioko Island, Equatorial Guinea, achieved significant reductions in malaria prevalence; however, progress subsequently stalled, leading to a proposal to develop and implement a highly effective malaria vaccine to increase impact. After conducting clinical trials of Sanaria® (Rockville, MD) Plasmodium falciparum (P. falciparum) sporozite vaccines against P. falciparum malaria, which demonstrated safety and efficacy, a larger phase 3 trial was planned to support vaccine licensure for specific target populations and eventual island-wide malaria elimination. The Equatorial Guinea Pilot Study for Recruitment, Screening and Participant Registry (EGRESPAR) assessed the health status of the target population and generated a registry of eligible children and adults. Households in areas with malaria prevalence ≥15% were randomly selected, aiming to register 2,100 healthy Equatoguineans divided equally into age groups of 1.5–9, 10–17, and 18–50 years. A total of 6,493 individuals from 1,807 households, who considered themselves or their children to be healthy, completed questionnaires; 2,021 were screened using phase 3 enrollment criteria, 643 were excluded, and 1,378 were entered into the registry. Among those screened, 13.6% had Plasmodium, 1.8% had Loa loa, 4.8% had hepatitis B, 0.5% had hepatitis C, and 2.1% had HIV. Adults were twice as likely to have clinically relevant medical conditions, such as obesity, hypertension, or diabetes, meeting exclusion criteria compared to children. In conclusion, there was a significant prevalence of infections and chronic medical conditions among Bioko Island residents who considered themselves or their children to be healthy and interested in clinical research participation, particularly in adults. The EGRESPAR successfully generated a registry to support the initiation of a large-scale phase 3 vaccine trial.
Financial support: The trial was funded by a public-private partnership, the Equatorial Guinea BIMEP, which is made up of the
Disclosures: S. L. Hofman is the founder, principal shareholder, and CEO of Sanaria Inc. L. Lemiale, B. K. L. Sim, L. W. P. Church, P. F. Billingsley, and T. L. Richie were full-time employees of Sanaria Inc. at the time the study was conducted. The other authors declare that they have no competing interests or conflicts of interest. The EGRESPAR received approval from the Equatorial Guinea National Ethics Committee.36 The study was also approved by two IRBs from Tanzanian and Swiss collaborators, respectively: the Ifakara Health Institute IRB and the Ethics Committee of Northwest and Central Switzerland.
Current contact information: María Silvia Angué López Mikue, Vicente Urbano Nsue Ndong Nchama, Gertrudis Owono Bidjimi, Marta Alene Owono, Escolastica Raquel Mansogo Maye, Martin Eká Ondo Mangue, Genaro Nsue Nguema Okomo, Beltrán Ekua Ntutumu Pasialo, Dolores Mbang Ondo Mandumbi, Fortunata Lobede Mochomuemue, José Raso, and Mathilde Riloha Rivas, Ministry of Health and Social Welfare, Equatorial Guinea (EGMOHSW), Malabo, Equatorial Guinea, E-mails: rusigr@live.com, viceurb2013@gmail.com, gertrudis.owono@gmail.com, owonoeyangmartaalene@gmail.com, mansogoe@gmail.com, drekaondo79@gmail.com, genarimetro@gmail.com, bekuapasialo123@gmail.com, doloresmbang1@yahoo.es, lobedefortunata2@gmail.com, jrasobi@yahoo.es, and mrriloha@gmail.com. Said Abdallah Jongo, Ali Hamad Said, Ali Mtoro, Kamaka R. Kassim, Ali Mohamed Ali, Ummi Abdul Kibondo, Thabit Athuman, Maxmillian Mpina, and Salim Abdulla, Ifakara Health Institute, Bagamoyo, Tanzania, E-mails: sjongo@ihi.or.tz, ahamad@ihi.or.tz, alimtoro@gmail.com, kramadhani@ihi.or.tz, aali@ihi.or.tz, uabdul@ihi.or.tz, tathuman@ihi.or.tz, mmpina@ihi.or.tz, and sabdulla@ihi.or.tz. Juan Carlos Momo Besaha, Jeremías Nzamio Mba Eyono, Jordan Michael Smith, and Elizabeth Nyakarungu, MCD Global Health, Malabo, Equatorial Guinea, E-mails: jmomo@mcd.org, jnzamio@mcd.org, jmsmith@mcd.org, and enyakarungu@mcd.org. Raul Chuquiyauri, Peruvian Ministry of Health, Iquitos, Perú, E-mail: rachuqui@gmail.com. Carlos Cortez Falla, United Nations Development Program, Caracas, Venezuela, E-mail: carlos.falla@undp.org. Guillermo A. García, MCD Global Health, Silver Spring, MD, E-mail: ggarcia@mcd.org. Claudia Daubenberger, Tobias Schindler, and Marcel Tanner, Swiss Tropical and Public Health Institute, Basel, Switzerland, E-mails: claudia.daubenberger@swisstph.ch, t.schindler@diaxxo.com, and marcel.tanner@swisstph.ch. Laurence Lemiale, B. Kim Lee Sim, Peter F. Billingsley, Stephen L. Hoffman, and Thomas L. Richie, Sanaria Inc. Rockville, MD, E-mails: llemiale@sanaria.com, ksim@sanaria.com, pbillingsley@sanaria.com, slhoffman@sanaria.com, and trichie@sanaria.com. L. W. Preston Church, Fred Hutch Cancer Center, Seattle, WA, E-mail: pchurch@fredhutch.org.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 2152 | 2152 | 316 |
Full Text Views | 43059 | 43059 | 43051 |
PDF Downloads | 88 | 88 | 79 |