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NCT ID: NCT03313128 Recruiting - Clinical trials for Rotavirus Infections

SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

Start date: October 1, 2017
Phase: N/A
Study type: Observational

This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique. The specific hypotheses are that: (1) access to improved sanitation is associated with increased oral rotavirus vaccine immunogenicity; (2) enteric infection concurrent to oral rotavirus vaccination is associated with reduced oral rotavirus vaccine immunogenicity; and (3) Environmental Enteric Dysfunction is associated with reduced oral rotavirus vaccine immunogenicity. Pregnant women will be enrolled from the intervention and control arms of a previous sanitation trial (NCT02362932) post-intervention and will be enrolled at no later than eight months' gestation and then followed to 4 months of age of the infant. Blood samples and faeces will be taken from the infant at the time of administration of the first dose of the oral rotavirus vaccine and four weeks after the second dose of the vaccine. The primary outcome of interest in the study is oral rotavirus vaccine immunogenicity among participating vaccinated infants. Seroconversion is defined as a ≥ fourfold rise in serum anti-rotavirus IgA titers between first dose of oral RV vaccine and 4 weeks (+/- 1 week) after second dose of oral RV vaccine. Enteric infections are defined as the presence of ≥ 1 of the following enteric infections in stool: adenovirus 40/41, rotavirus A, norovirus GI/GII, Salmonella spp. (including serovars Typhi and Paratyphi), Campylobacter spp. (C. jejuni, C. coli, C. lari), Shigella spp. (S. boydii, S. sonnei, S. flexneri, S. dysenteriae), Clostridium difficile Toxin A/B, enterotoxigenic Escherichia coli (ETEC) LT/ST, E. coli O157, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Yersinia enterocolitica, Vibrio cholerae, Giardia lamblia, Entamoeba histolytica, and Cryptosporidium spp. (C. parvum, C. hominis). Environmental Enteric Dysfunction is measured via a combined disease activity score including faecal markers of intestinal inflammation and permeability: neopterin, α-1 antitrypsin, and myeloperoxidase in stool.

NCT ID: NCT03284710 Recruiting - HIV Infections Clinical Trials

Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

Start date: June 19, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

NCT ID: NCT03231449 Active, not recruiting - Stroke Clinical Trials

A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

Start date: February 1, 2017
Phase: N/A
Study type: Observational

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

NCT ID: NCT03187067 Not yet recruiting - Pneumonia Clinical Trials

Pediatric Pneumonia Lung Ultrasound

Start date: June 2017
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries

NCT ID: NCT03133572 Not yet recruiting - Asphyxia Neonatorum Clinical Trials

Neonatal Resuscitation With Supraglottic Airway Trial

Start date: November 2017
Phase: N/A
Study type: Interventional

Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel. OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce mortality at 7 days, morbidity in neonatal encephalopathy (NE) in asphyxiated neonates. STUDY DESIGN, SETTING AND POPULATION A multi-centre randomized clinical trial will be conducted at Central Hospital, Beira, Mozambique and at Mulago Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines. UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.

NCT ID: NCT03076359 Recruiting - HIV/AIDS Clinical Trials

Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique

Start date: June 10, 2015
Phase: N/A
Study type: Interventional

The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.

NCT ID: NCT03060629 Recruiting - HIV-1 Clinical Trials

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

Start date: November 3, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

NCT ID: NCT02967003 Recruiting - Clinical trials for Hemorrhagic Fever, Ebola

Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

NCT ID: NCT02910934 Recruiting - Malaria Clinical Trials

Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique

Start date: January 10, 2017
Phase: N/A
Study type: Interventional

This study aims to provide National Malaria Control Programs (NMCP), international donors and other key stakeholders with clear evidence on the impact and cost-effectiveness of using indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high malaria transmission area that has universal long-lasting insecticidal net (LLIN) coverage. This is an interventional study with IRS serving as the research intervention. The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This is a high transmission area with a malaria parasite prevalence of 54% in children. The Ministry of Health distributed LLINs in Mopeia in 2014-2015. The NMCP through funding from President's Malaria Initiative Africa Indoor Residual Spraying Project (PMI-AIRS) was able to cover half a district with indoor residual spraying. A simplified census took place in mid-2016 to determine the number of children five years of age and under in the district and enumerate and map the households to assist in implementation. From the 115 villages/bairros existent in Mopeia, 86 clusters were randomized in a government randomization ceremony to either receive IRS with Actellic or maintain no IRS. The IRS was implemented through a partnership between the NMCP and PMI-AIRS according to standard operational and consent procedures. From each cluster, a cohort of 18 children five years of age and under will be followed monthly to assess malaria incidence at the community level in both IRS and non-IRS villages. There will be 774 children in the IRS villages and 774 children in the no-IRS villages (total cohort will be 1548). Additionally, the routine health centre reporting system will be strengthened to assess malaria incidence in children five years of age and under by passive case detection. Two cross sectional studies in April 2017 and April 2018, will assess changes in net use, health seeking behaviour and malaria prevalence at the community level. Entomological data will be collected from both IRS and non-IRS areas to assess the vector dynamics and insecticide resistance pattern of the local vector populations from sprayed and unsprayed areas. Data on the costs of the implementation as well as health-related expenditures at health system and household levels will be collected prospectively throughout the study. These costs will be determined using both health system and societal perspectives. The incidence rate in IRS and no-IRS areas will be combined with the micro-costing data to calculate the cost per case averted at community and health facility level. These findings will be disseminated to the NMCP and international donors and stakeholders to complement the WHO guidance on combining indoor residual spraying and long-lasting insecticidal nets.

NCT ID: NCT02762851 Recruiting - Heart Failure Clinical Trials

Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

Start date: June 2016
Phase: Phase 4
Study type: Interventional

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 3,500 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.