Mayanja, Y, Mukose AD, Nakubulwa S, Omosa-Manyonyi G, Kamali A, Guwatudde D.  2016.  Acceptance of Treatment of Sexually Transmitted Infections for Stable Sexual Partners by Female Sex Workers in Kampala, Uganda., 2016. PloS one. 11(5):e0155383. Abstract

The prevalence of sexually transmitted infections (STIs) among female sex workers (FSWs) in sub-Saharan Africa remains high. Providing treatment to the affected FSWs is a challenge, and more so to their stable sexual partners. There is scanty research information on acceptance of STI treatment for stable sexual partners by FSWs. We conducted a study to assess acceptance of STI treatment for stable sexual partners by FSWs, and to identify factors associated with acceptance.

Bergin, P, Langat R, Omosa-Manyonyi G, Farah B, Ouattara G, Park H, Coutinho H, Laufer D, Fast P, Verlinde C, Bizimana J, Umviligihozo G, Nyombayire J, Ingabire R, Kuldanek K, Cox J, McMorrow M, Fidler S, Karita E, Gilmour J, Anzala O.  2016.  Assessment of anti-HIV-1 antibodies in Oral and Nasal Compartments of Volunteers from Three different Populations., 2016 May 26. Journal of acquired immune deficiency syndromes (1999). Abstract

In this study, we assessed the feasibility of collecting standardized nasal and salivary samples at centers in Nairobi (Kenya), Kigali (Rwanda) and London (UK) using different collection devices and media (Synthetic absorptive matrices versus flocked swabs, and Salimetrics Oral swabs versus whole oral fluid collection). We detected anti Gag (p24) and envelope (gp140) antibodies in both nasal fluid and salivary collections from all HIV-infected individuals, and cross-reactive anti-p24 antibodies were detected in 10% of HIV-uninfected individuals enrolled at one site. Collections from the nasal turbinates were comparable to samples collected deeper in the nasopharyngeal tract, and the yield of anti-p24 IgA in the whole oral fluid samples was higher than in samples collected from the parotid gland. We noted a trend toward reduced levels of anti-HIV antibody in the volunteers receiving anti-retroviral therapy (ART). Levels of antibodies were stable over multiple collection visits. Overall, this study shows that nasal and salivary samples can be collected in a standardized manner over repeated visits in both low and high resource settings. These methods may be used in support of future HIV vaccine clinical trials.


Omosa-Manyonyi, G, Mpendo J, Ruzagira E, Kilembe W, Chomba E, Roman F, Bourguignon P, Koutsoukos M, Collard A, Voss G, Laufer D, Stevens G, Hayes P, Clark L, Cormier E, Dally L, Barin B, Ackland J, Syvertsen K, Zachariah D, Anas K, Sayeed E, Lombardo A, Gilmour J, Cox J, Fast P, Priddy F.  2015.  A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults., 2015. PloS one. 10(5):e0125954. Abstract

Sequential prime-boost or co-administration of HIV vaccine candidates based on an adjuvanted clade B p24, RT, Nef, p17 fusion protein (F4/AS01) plus a non-replicating adenovirus 35 expressing clade A Gag, RT, Int and Nef (Ad35-GRIN) may lead to a unique immune profile, inducing both strong T-cell and antibody responses.


Schmidt, C., JO-MKMNKBWGPJ, L. G. Bekker, E. Chomba KNNSCLWMJG, and J. Cox, S. Allen DSFLCPE.  2014.  Long-Term Follow-up of Study Participants from Prophylactic Hiv Vaccine Clinical Trials in Africa. Hum Vaccin Immunother. 10, no. 3:714-23.
Mutua, G., MMKO-MRKP-SLJWG, and G. Gray, L. G. Bekker BLSPBDCF.  2014.  Major Negative Social Impacts Are Rare in Phase 1 Hiv Vaccine Trials in Africa. AIDS Res Hum Retroviruses. 30 Suppl 1:A190-1.
Karita, E., AGBNOJIOOBPJ, H. Park, A. Gumbe CWVCCBBKSCL, B. Farah, P. Hayes ZSLDBIHDKMF, and T. Hironaka, T. Shu HMSPAFGCLMTEC, Laufer D.  2014.  Clinical Safety and Immunogenicity of Two Hiv Vaccines Sev-G (Np) and Ad35-Grin in Hiv-Uninfected, Healthy Adult Volunteers. AIDS Res Hum Retroviruses. 30 Suppl 1:A85.
Hayes, P., FO-MMKRKMNGJE, O. Anzala, F. Roman BBEEHSFPCPBJM, and Gilmour J.  2014.  Assessment of Viral Inhibition Activity in Low Seroprevalent Adenovirus-35 Vectored Hiv Vaccines+/- Adjuvanted Protein or Electroporated DNA. AIDS Res Hum Retroviruses. 30 Suppl 1:A188.
Omosa-Manyonyi, G., LMPBFOOOIREHP, and R. Ndambuki, P. Fast LPADFO.  2014.  Implementation of a Training Program to Standardize Mucosal Sample Collection and Processing at Multiple Laboratories in Eastern Africa. AIDS Res Hum Retroviruses. 30 Suppl 130 Suppl 1:A236-7.
Omosa-Manyonyi, G., PMFBLLCBFHGBP, and Anzala GJO.  2014.  Acceptability and Feasibility of Repeated Mucosal Specimen Collection in Clinical Trial Participants in Kenya. PLoS One. 9, no. 10:e110228..
Manyonyi, G., JBLMFNOOWKWKS, M., Fowke KAKRO.  2014.   Enhancing capacity of research ethics review committees in developing countries: The Kenyan example. South African Journal Of Bioethics And Law. 7(2), 59-63. :doi:10.7196/sajbl.308.


Gaudensia Mutua, Gloria Omosa, HPPBDLPAJL, Pat Fast, Jill Gilmour OABF.  2012.  Uptake and tolerability of repeated mucosal specimen collection in two Phase 1 AIDS preventive vaccine trials in Kenya. Retrovirology . 9(Suppl 2):122.


Omosa-Manyonyi GS, Jaoko W, AOWOHS, et al.  2011.  Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya.. PLoS ONE . 6(1):e14580.


Walter Jaoko, Etienne Karita, KKGO-MSASTEABMS, Graham, Richard A. Koup RBCSLDBFOAT, Claude M. Muvunyi, Jean Bizimana TT-FPBPHJ, Martin Ho, Kelley Loughran WKGSHTMBJ, Josephine H. Cox, Claudia Schmidt JGGNPFJBJ.  2010.  Safety and Immunogenicity Study of Multiclade HIV-1 Adenoviral Vector Vaccine Alone or as Boost following a Multiclade HIV-1 DNA Vaccine in Africa. PLoS ONE . 5( 9):e12873.


Jaoko WG, Ogutu H, WMNNOGMFSVSBSRRJ, OA. N-AAJ &.  2009.  Pregnancy rates among female participants in phase I and phase IIA AIDS vaccine clinical trials in Kenya. East African Medical Journal . 86(9)
Karita E, Ketter N, PMAKKNAJMRMKPAO, Sanders EJ, Mwangome M ABBAOFABYSAUK.  2009.  CLSI-derived hematology and biochemistry reference intervals for healthy adults in eastern and southern Africa. PLoS One.. 4(2):e4401. AbstractWebsite

Clinical laboratory reference intervals have not been established in many African countries, and non-local
intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using
laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE
assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology,
immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial


Walter Jaoko, Frederick N Nakwagala, OAGOMJ, Birungi, Annet Nanvubya FBKBHOSWLM, Wambui Waruingi, Jane Odada MOJIJN-ACKEM, Patricia Fast, Claudia Schmidt JGTTCSBBLD,, Bruce Johnson AMLNPHMBPHT´aˇs HAMM, Job Bwayo PK.  2008.  Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine. :2788—2795.
OMOSA, DRMANYONYISUSANGLORIAK.  2008.  Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Jaoko W, Nakwagala FN, Anzala O, Manyonyi GO, Birungi J, Nanvubya A, Bashir F, Bh. Vaccine. 2008 May 23;26(22):2788-95. Epub 2008 Mar 31.. : IBIMA Publishing Abstract
The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.


Barry S Peters, Walter Jaoko, EVGPPFCSJG, Mampedi Bogoshi, Gloria Omosa-Manyonyi LDBFTTP-ABARC, Pieterse, Wendy Stevens RTBBAMMJMIGPTHJJA, bwayo.  2007.  Studies of a prophylactic HIV1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity. Vaccine. 25(11):2120-7.


Peters, BS, Jaoko W, Vardas E, Panayotakopoulos G, Fast P, Klavinskis L, Bogoshi M, Omosa-Manyonyi G, Dally L, Klavinskis L, Farah B, Tarragona T, Bart P-A, Robinson A, Pieterse C, Stevens W, Thomas R, Barin B, McMichael AJ, McIntyre JA, Pantaleo G, Hanke T´aˇs, Bwayo JJ.  2006.  Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: Effects of dosage and route on safety and immunogenicity. Abstract

Two parallel studies evaluated safety and immunogenicity of a prophylactic HIV-1 vaccine in 192 HIV-seronegative, low-risk volunteers. Modified vaccinia virus Ankara (MVA) and plasmid DNA (pTHr) expressed HIV-1 clade A gag p24 and p17 fused to a string of 25 overlapping CD8+ T cell epitopes (HIVA). Methods: These studies compared intramuscular, subcutaneous, and intradermal MVA at dosage levels ranging from 5×106–2.5×108 pfu. In Study IAVI-010, DNA vaccine was given as a prime at months 0 and 1, followed by MVA as a boost at months 5 and 8. In Study IAVI-011, MVA alone was given at months 0 and 2. Regular safety monitoring was performed. Immunogenicity was measured by the interferon (IFN)- ELISPOT assay on peripheral blood mononuclear cells (PBMC). Results: No serious adverse events were attributed to either vaccine; most adverse events were mild or moderate, although MVA resulted in some severe local reactions. Five vaccine recipients had at least one positive IFN- ELISPOT response, but none were sustained. Conclusion: This HIV-1 vaccine candidate was in general safe and well-tolerated. Local reactions were common, but tolerable. Detectable immune responses were infrequent.



Sabina Wakasiaka, Job Bwayo, JN-AGOWJWWHO&.  2004.  Kenya AIDS Vaccine Initiative HIV Vaccine Peer Leaders’ Training Manual.

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