88 results match your criteria: "Setshaba Research Centre[Affiliation]"
Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.
N Engl J Med
July 2020
From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).
Background: Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.
Methods: Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety.
Age-Specific Risk Scores Do Not Improve HIV-1 Prediction Among Women in South Africa.
J Acquir Immune Defic Syndr
October 2020
Department of Epidemiology, University of Washington, Seattle, WA.
Background: HIV-1 risk scoring tools could help target provision of prevention modalities such as pre-exposure prophylaxis. Recent research suggests that risk scores for women aged 18-45 may not predict risk well among young women aged 18-24. We evaluated the predictive performance of age-specific risk scores compared with the existing non-age-specific VOICE risk score, developed for women aged 18-45.
View Article and Find Full Text PDFIntegrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.
J Int AIDS Soc
May 2020
University of Washington, Seattle, WA, USA.
Introduction: Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
View Article and Find Full Text PDFSafety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines.
PLoS Med
February 2020
Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.
Background: HVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced immune responses.
Methods And Findings: A phase 1-2 randomized double-blind placebo-controlled trial enrolled 252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015. Vaccine recipients received ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59 at months 3, 6, and 12.
Contraceptive implant uptake in Kenya versus South Africa: Lessons for new implantable technologies.
Contraception
April 2020
RTI International, Women's Global Health Imperative, San Francisco, CA, USA; Center for AIDS Prevention Studies, University of California - San Francisco, San Francisco, CA, USA. Electronic address:
Final Analysis of a Trial of M72/AS01 Vaccine to Prevent Tuberculosis.
N Engl J Med
December 2019
From the International AIDS Vaccine Initiative (IAVI) (D.R.T.), the South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology (M.H., T.J.S., M.T.), and the Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (F.T., R.J.W.), University of Cape Town, TASK Applied Science (E.V.B., A.D.), and Stellenbosch University (A.D.), Cape Town, the Be Part Yoluntu Centre, Paarl (E.H.), the Aurum Institute, Klerksdorp Research Centre, Klerksdorp (J.C.I.), the Aurum Institute, Tembisa Research Centre, Tembisa (J.C.I.), Setshaba Research Centre, Pretoria (M. Malahleha), and the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South African Medical Research Council Collaborating Centre for HIV/AIDS and TB, and National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, University of the Witwatersrand, Johannesburg (N.M.) - all in South Africa; GlaxoSmithKline, Wavre, and GlaxoSmithKline, Rixensart - both in Belgium (O.V.D.M., B.S., E.J.A., A.B., M.-A.D., P.G., D.M.V., T.G.P., F.R.); the IAVI, New York (A.M.G., T.G.E., M.L.); Zambart, University of Zambia (H.M.A.), and the Centre for Infectious Disease Research in Zambia (M. Muyoyeta) - both in Lusaka; the London School of Hygiene and Tropical Medicine (H.M.A.) and Francis Crick Institute and the Department of Medicine, Imperial College London (R.J.W.) - all in London; Johns Hopkins University Center for Tuberculosis Research, Baltimore (N.M.); the Kenya Medical Research Institute Centre for Respiratory Diseases Research, Nairobi (V.N.); and the Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland (F.T.).
Background: Results of an earlier analysis of a trial of the M72/AS01 candidate vaccine against showed that in infected adults, the vaccine provided 54.0% protection against active pulmonary tuberculosis disease, without evident safety concerns. We now report the results of the 3-year final analysis of efficacy, safety, and immunogenicity.
View Article and Find Full Text PDFEngaging study participants in interpreting results: lessons from the TRIO study in Kenya and South Africa.
Int J Womens Health
July 2019
Women's Global Health Imperative, RTI International, San Francisco, CA, USA.
Women account for 56% of new HIV infections in sub-Saharan Africa. Multipurpose Prevention Technologies (MPTs) are promising interventions because they combine HIV prevention with a less stigmatizing indication, such as pregnancy. We conducted a study with three placebo-only MPT products in Kisumu, Kenya and Soshanguve, South Africa, to assess preferences for attributes of tablets, vaginal rings and injectable products for dual prevention of HIV and pregnancy (TRIO Study).
View Article and Find Full Text PDFTwo Birds with One Stone: Health Care Providers' Perspectives about Prevention Technologies in Kenya and South Africa.
J Int Assoc Provid AIDS Care
June 2020
2 RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA, USA.
To meet the reproductive health needs of women, especially those in sub-Saharan Africa, multipurpose prevention technologies (MPTs) that combine pregnancy and HIV prevention into a single product could be highly beneficial. This qualitative study with health care providers in Kenya and South Africa examined health system factors that may facilitate or inhibit the delivery of these MPTs. Twelve qualitative interviews were conducted with health care providers at each site (24 interviews total).
View Article and Find Full Text PDF"We are not the same": African women's view of multipurpose prevention products in the TRIO clinical study.
Int J Womens Health
February 2019
Women's Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA,
Purpose: Unintended pregnancy and HIV infection present dual risks for young women in sub-Saharan Africa. New multipurpose prevention technologies (MPTs) are in development to simultaneously prevent unintended pregnancy and HIV, but there is a need for end-user research to ensure these products suit women's needs. The Tablet, Rings and Injectables as Options (TRIO) for women study took place in Kisumu, Kenya, and Soshanguve, South Africa, with the goal of eliciting young women's feedback on three potential MPTs.
View Article and Find Full Text PDFYoung Women's Stated Preferences for Biomedical HIV Prevention: Results of a Discrete Choice Experiment in Kenya and South Africa.
J Acquir Immune Defic Syndr
April 2019
RTI Health Solutions, Research Triangle Park, NC.
Background: Integrating end-user perspectives into the design of new biomedical HIV prevention products is recognized as vital to informing the product development pipeline.
Setting: Kisumu, Kenya; and Soshanguve, South Africa.
Methods: We conducted a discrete choice experiment survey with 536 women aged 18-30 years to assess preferences for hypothetical HIV prevention products characterized by the attributes of efficacy, pregnancy prevention, delivery form, dosing frequency, and side effects.
Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial.
Int J Tuberc Lung Dis
January 2019
University of Cape Town, Cape Town, South Africa.
Setting: Seven tuberculosis (TB) clinics in South Africa.
Objective: As both purified protein derivative (PPD) and a -specific skin test (C-Tb) contain region of difference 1 (RD1) antigens, we conducted a study to evaluate whether there was any interaction between the two during concomitant and separate administration in patients with newly diagnosed culture-positive TB.
Design: Adult patients with active TB ( = 456, 20% human immunodeficiency virus infected) were randomised to receive only C-Tb, only PPD, or concomitant injection of both C-Tb and PPD using the Mantoux technique.
Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial.
Lancet Infect Dis
November 2018
Wits RHI, University of the Witwatersrand, Johannesburg, South Africa.
Background: Young women in southern Africa have substantial risk of HIV acquisition. Female-controlled biomedical interventions are needed to mitigate this risk. We aimed to assess the safety and efficacy of a pericoitally applied tenofovir 1% gel.
View Article and Find Full Text PDFPhase 2b Controlled Trial of M72/AS01 Vaccine to Prevent Tuberculosis.
N Engl J Med
October 2018
From GlaxoSmithKline, Wavre, Belgium (O.V.D.M., M.-A.D., T.S., E.J.A., A.K.A., A.B., P.G.); South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology (M.H., T.J.S., M.T.), and Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (R.J.W., F.T.), University of Cape Town, Task Applied Science (E.V.B., A.D.), Stellenbosch University (A.D.), and Aeras Global TB Vaccine Foundation (D.R.T.) Cape Town, Setshaba Research Centre, Pretoria (M. Malahleha), the Aurum Institute, Klerksdorp and Tembisa Research Centres (J.C.I.), and the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South African Medical Research Council Collaborating Centre for HIV/AIDS and TB, and National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, University of the Witwatersrand (N.M.), Johannesburg, and Be Part Yoluntu Centre, Paarl (E.H.) - all in South Africa; Kenya Medical Research Institute, Nairobi (V.N.); Francis Crick Institute (R.J.W.), the Department of Medicine, Imperial College London (R.J.W.), and the London School of Hygiene and Tropical Medicine (H.M.A.) - all in London; Centre for Infectious Disease Research in Zambia (M. Muyoyeta, G.H.) and Zambart, University of Zambia (H.M.A.) - both in Lusaka, Zambia; the Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland (F.T.); and Aeras, Rockville (G.L.B., A.M.G., T.G.E.), and Johns Hopkins University Center for Tuberculosis Research, Baltimore (N.M.) - both in Maryland.
Background: A vaccine to interrupt the transmission of tuberculosis is needed.
Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01 tuberculosis vaccine in Kenya, South Africa, and Zambia. Human immunodeficiency virus (HIV)-negative adults 18 to 50 years of age with latent M.
C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.
PLoS One
March 2019
UCT, Cape Town, South Africa.
Background: C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons.
Methods: Asymptomatic South African contacts <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres.
Perspectives of South African youth in the development of an implant for HIV prevention.
J Int AIDS Soc
August 2018
RTI International, Women's Global Health Imperative, San Francisco, California, USA.
Introduction: Implants are a new dosage form in development for HIV pre-exposure prophylaxis (PrEP) with potential for high adherence given that they are provider-administered and are intended for long-acting protection. Integrating end-user preference into early stage product development may further overcome challenges with future product uptake and adherence. Hence, we sought to optimize the design of a PrEP implant in early-stage development by gathering opinions about implant attributes from potential end-users in South Africa.
View Article and Find Full Text PDFInflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study.
Sex Transm Infect
February 2019
Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa.
Objectives: Vaginal dysbiosis and STIs are important drivers of the HIV epidemic and reproductive complications. These conditions remain prevalent, partly because most cases are asymptomatic. We have shown that inflammatory cytokines interleukin (IL)-1α, IL-1β and interferon-γ-induced protein (IP)-10 are biomarkers for detecting asymptomatic STIs and vaginal dysbiosis (bacterial vaginosis (BV) or intermediate microbiota).
View Article and Find Full Text PDF"It Was Not My Aim to Sleep There": The Impact of Timing and Location of Sex on Adherence to Coitally-Dependent HIV Pre-exposure Prophylaxis.
AIDS Behav
November 2018
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Corner Esselen and Klein Street, Hillbrow, Johannesburg, 2001, South Africa.
The FACTS 001 trial found that vaginal pre- and post-coital application of 1% tenofovir gel did not prevent HIV-1 infection amongst young South African women. The trial included a multi-faceted approach to adherence support and collected objective and self-reported adherence measures. Using qualitative data collected from a random sub-set of FACTS 001 participants (135 in-depth interviews at product discontinuation and 13 focus group discussions at dissemination of trial results), we explore the importance of 'place' and 'timing' in shaping acts of sexual intimacy and product adherence.
View Article and Find Full Text PDFSubtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial.
Lancet HIV
July 2018
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Background: Modest efficacy was reported for the HIV vaccine tested in the RV144 trial, which comprised a canarypox vector (ALVAC) and envelope (env) glycoprotein (gp120). These vaccine components were adapted to express HIV-1 antigens from strains circulating in South Africa, and the adjuvant was changed to increase immunogenicity. Furthermore, 12-month immunisation was added to improve durability.
View Article and Find Full Text PDFThe Tablets, Ring, Injections as Options (TRIO) study: what young African women chose and used for future HIV and pregnancy prevention.
J Int AIDS Soc
March 2018
Women's Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA.
Introduction: Preventing HIV and unintended pregnancies are key global health priorities. To inform product rollout and to understand attributes of future multipurpose prevention technologies (MPT) associated with preference and use, we evaluated three placebo delivery forms: daily oral tablets, a monthly vaginal ring, and two monthly intramuscular injections in TRIO, a five-month study among young Kenyan and South African women.
Methods: HIV-negative, sexually active, non-pregnant women aged 18 to 30 were enrolled and randomized to use each placebo delivery form for one month (stage 1).
Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.
AIDS Behav
August 2018
Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA.
End-user input is critical to inform development of multipurpose prevention technology (MPT) products that prevent HIV and pregnancy. The TRIO Study, conducted in Kenya and South Africa, enrolled 277 HIV-negative women aged 18-30 in a randomized cross-over study to use each placebo MPT (daily oral tablets, monthly injections, and monthly vaginal ring) for one month. At the end of each month, participants rated how much they liked using the product on a 5-point Likert scale (5 = liked very much).
View Article and Find Full Text PDFImmunogenicity and safety of one or two doses of the quadrivalent meningococcal vaccine MenACWY-TT given alone or with the 13-valent pneumococcal conjugate vaccine in toddlers: A phase III, open-label, randomised study.
Vaccine
March 2018
GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium. Electronic address:
Background: We evaluated the immunogenicity and safety of 1 and 2 doses of quadrivalent meningococcal serogroup A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT) given alone or co-administered with 13-valent pneumococcal conjugate vaccine (PCV13) in toddlers.
Methods: In this phase III, open-label, controlled, multicentre study (NCT01939158), healthy toddlers aged 12-14 months were randomised into 4 groups to receive 1 dose of MenACWY-TT at month (M) 0 (ACWY_1), 2 doses of MenACWY-TT at M0 and M2 (ACWY_2), MenACWY-TT and PCV13 at M0 (Co-ad), or PCV13 at M0 and MenACWY-TT at M2 (PCV13/ACWY). Immune responses were assessed 1 month post-each vaccination.
Factors influencing access of pregnant women and their infants to their local healthcare system: a prospective, multi-centre, observational study.
BMC Pregnancy Childbirth
January 2018
GSK (formerly employee of Novartis Vaccines Division), Cambridge, MA, USA.
Background: The successful implementation of maternal vaccination relies on results of clinical trials, considering the prenatal and postnatal attendance at selected healthcare institutions. This study evaluated factors influencing maternal/infant access to healthcare facilities to identify potential barriers to participation in future clinical trials on maternal vaccination.
Methods: In this prospective, multi-centre, observational study, pregnant women (N = 3243) were enrolled at ten sites across Panama, the Dominican Republic, South Africa, and Mozambique between 2012 and 2014.
End-Users' Product Preference Across Three Multipurpose Prevention Technology Delivery Forms: Baseline Results from Young Women in Kenya and South Africa.
AIDS Behav
January 2018
Women's Global Health Imperative, RTI International, 351 California St Suite 500, San Francisco, CA, 94104, USA.
A multipurpose prevention technology (MPT) that combines HIV and pregnancy prevention is a promising women's health intervention, particularly for young women. However, little is known about the drivers of acceptability and product choice for MPTs in this population. This paper explores approval ratings and stated choice across three different MPT delivery forms among potential end-users.
View Article and Find Full Text PDFBackground: Monthly specimens collected from FEM-PrEP-a Phase III trial [1] were investigated for the detection of acute HIV (AHI) infection.
Objectives: To evaluate the efficiency of the study-specific HIV algorithm in detecting AHI, and the performance of each of the serological and molecular tests used in diagnosing new infections, and their contribution to narrowing the window period.
Study Design: A total of 83 pre-seroconversion specimens from 61 seroconverters from the FEM-PrEP trial were further analyzed in a sub-study.
Performance of serological and molecular tests within acute HIV infection.
J Clin Virol
August 2017
Institute of Tropical Medicine, Antwerp, Belgium.
Background: Early diagnosis of acute HIV infection can be challenging and is critical in regards to early therapeutic decision making.
Objectives: To evaluate the performance of different HIV tests in detecting early infections.
Study Design: A total of 83 leftover specimens of 61 study participants who seroconverted were used in this sub-study.