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This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and heterologous challenge infection.
This study will aim to recruit at least 70 children who participated in the iMAP2 study whose mothers received a pertussis vaccine in pregnancy as part of the iMAP2 trial and at least 15 children born to mothers who did not receive a pertussis vaccine in pregnancy. Blood samples will be obtained prior to and one month after the routine preschool booster vaccination and vaccine responses compared between children whose mothers received one of two pertussis vaccines or no pertussis vaccine in pregnancy. Children will be vaccinated with the routine booster vaccines by the study team on the same visit as the pre-vaccination bloods are taken.
The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.
Since the introduction of pneumococcal conjugate vaccines, this research group has conducted several carriage studies. These were at key points in the evolution of the pneumococcal immunisation schedule, with regard to the introduction of PCV7, the change to PCV13 and the impending change in number of doses of PCV13 given to infants. The last carriage study, conducted in 2015/16 identified interesting changes in carriage patterns which will further be explored by the current planned study. Nasopharyngeal swabs and saliva swabs will be taken from healthy subjects and any pneumococci present will be cultured and serotyped using standard methods, as per our previous studies (Hussain et al., 2005; Flasche et al., 2011; van Hoek et al., 2014).
This study aims to implement and test the efficacy of photovoice, Short Messaging Service (SMS) and phone call reminders in improving childhood immunization coverage (uptake, timeliness and completion rates) and reducing incidence of vaccine-preventable diseases (VPDs) among infants in Nigeria
Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness. The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.
Like many developing countries, Pakistan faces a public health challenge of low and incomplete immunization rates of children, only 54% of children aged 12 to 24 months are fully immunized, which leaves children susceptible to vaccine-preventable diseases. The Expanded Program on Immunization (EPI) is a low-cost and effective health intervention, but the uptake is low, delayed, and completion rates are poor. Door-to-door campaigns can increase coverage, but are extremely expensive. Incentive-based approaches have been rigorously demonstrated to effectively increase take-up and completion rates of immunization, and there is substantial evidence that small incentives can have a large impact on the take up of preventative health behavior in general. There are two major constraints to scaling these findings, however. This study will attempt to find the most effective incentive design that helps increase the coverage of full immunization rates among children between the ages of 0 - 24 months in the city of Karachi, Pakistan. The study proposes to conduct a randomized control trial involving small conditional cash transfers (mCCTs) to determine the optimal CCT amount (high versus low), schedule (flat versus increasing) and design (lottery versus sure payment) that would lead to the highest increase in immunization rates. Interactive Research and Development's digital immunization registry will be used to enrol and randomize the study participants and generate CCTs disbursed through a mobile money transfer platform and mobile top - ups . The three year study will be conducted in Karachi, Pakistan enrolling a sample of 11,200 children, 0-2 years of age. The study aims to provide evidence regarding the most cost-effective way to structure incentives in terms of size, schedule, and design; and address the challenge of delivering small incentives in a way that is inexpensive, logistically simple, and not subject to leakage.
Pakistan has one of the highest infant mortality rates in the world in part, due to the low coverage (54%) for all basic vaccinations. Low uptake, lack of awareness among parents to complete the recommended immunization schedule and inability to remember vaccine appointments are some of the key factors hindering improvement in uptake of immunization services. On the supply side, ineffective methods to track children's' vaccine doses means that there is no reliable mechanism to verify vaccine administration and estimate accurate immunization coverage. This study proposes to develop and test two types of silicon bracelets for children to stimulate immunization demand and simultaneously address supply side verification issues. These bracelets use a combination of numbers and symbols to denote the age of the child and due vaccines and are designed for illiterate or uneducated mothers; are low-cost and adaptable to most local settings. At the time of vaccine administration, the appropriate symbol denoting the vaccine on the bracelets is punched and therefore the bracelets can serve as effective reminders for mothers for timely immunization of their child and as a tool for vaccinators to verify vaccine administration and coverage. An individually randomized, three-arm parallel group design randomized control trial will be conducted with equal allocation in the two treatment groups and control group. Children in intervention group A will receive the simple silicon bracelets, children in intervention group B will receive the bracelets developed by Alma Sana Inc. and children in the Control group will not receive any intervention. The impact of these immunization reminder bracelets on immunization coverage and timeliness will be evaluated through a randomized control trial (RCT) across 4 immunization centers in Karachi. To evaluate the bracelets' impact, variables of interest-coverage and timeliness rates of pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine will be compared between Group A and the Control Group and Group B and the Control Group. Proposed results include increase in immunization coverage and timeliness of Pentavalent-3/Pneumococcal Conjugate Vaccine (PCV-3)/Polio-3 and Measles-1 in the intervention versus control group. The study will provide evidence of the bracelet's effectiveness for the global health community and provide a simple tool for strengthening routine immunization efforts in Pakistan.
This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age and randomize them to either fractional or full dose IPV. Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected communities of Bin qasim Town Karachi who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D will be eligible for enrollment. The investigators will exclude children who are found acutely ill or those requiring emergent medical care/hospitalization at the time of enrollment. The investigators will use the Demographic Surveillance System (DSS) in the four study areas to identify the households with eligible children. The children of the parents who agree to participate in the study will be screened for eligibility by the trained research associates. After randomization into four different arms, the study trained research vaccinators will administer the IPV or fIPV as per randomization. Children will be observed in the center for 30 minutes after vaccination before leaving for home. Parents/guardians of all the participants will also be requested to immediately report any adverse effect occurring later. This study will be conducted in compliance with this protocol, GCP guidelines and all applicable international and local regulatory requirements. The study has approval by the Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be conducted in AKU's field research sites from where subjects will be recruited. The Clinical Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures conducted at CTU such as randomization, management of vaccines (storage, dispensing and incineration), and other responsibilities agreed in writing. Adverse events following vaccine administration will be monitored and all serius adverse events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are licensed in Pakistan and in routine use.
To collect the immunisation history of participants enrolled in a previous vaccine study (REC 09/H0604/107) in order to assess the influence of genetic variation on the level of immunity to routine immunisations.