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Official websites use. Share sensitive information only on official, secure websites. It was developed for use within the expanded program on immunizations EPI for African children. Methods : An open-label, randomized, controlled phase 2 trial was conducted in healthy, adult Thai volunteers. Seven vaccine regimens with and without antimalarial drugs dihydroartemisinin-piperaquine plus a single low dose primaquine were assessed. Liquid chromatography was used to measure piperaquine, primaquine and carboxy-primaquine concentrations. Results : volunteers were enrolled and study participants completed the 6 months follow-up period. There was no indication that drug concentrations were influenced by vaccine regimens or the antibody levels by the drug regimens. Adverse events were similarly distributed between the seven treatment groups. No serious adverse events attributable to the study interventions were detected. It provides incomplete protection against uncomplicated and severe malaria over a limited time span. In the aforementioned Phase 3 trial, the vaccine was more protective in children living in lower transmission settings presumably more aligned with an elimination setting than in higher transmission settings, perhaps due to lower forces of infection. Mathematical models suggest that adding a temporarily effective vaccine to other basic malaria control measures could interrupt parasite transmission permanently if implemented at scale. To accelerate progress towards this ambitious goal, mass drug administrations MDA have been piloted in malaria hot-spots in addition to the conventional malaria control strategies; widespread use of long-lasting insecticide-treated bed-nets and early diagnosis and effective treatment. A longer lasting or even permanent interruption of transmission could potentially be achieved by combined mass vaccination and drug administration campaigns. While some studies have been conducted in African 10 and American adults 4 , 11 the vaccine has not been tested in Asia. One hundred and ninety-three volunteers including 3 replacements were randomized into one of seven treatment groups Table 1. Two participants were lost to follow up and one participant withdrew before completing the vaccination schedule Figure 1. The baseline characteristics were well balanced across the groups Table 2. Forty-five percent of the enrolled participants were male. The median age was The median range of day 7 piperaquine concentrations during the first month was The median trough concentration before the start of the second month of treatment was 6. There were no significant differences between the piperaquine, primaquine or carboxy-primaquine concentrations at each sampling time point in study participants who received the standard or fractional vaccine doses Figure 4. The population pharmacokinetic model for piperaquine described the data well and suggested a relatively lower bioavailability of piperaquine compared to the prior study, i. The vaccine dose i. Simulation-based diagnostics and standard goodness-of-fit plots showed an excellent predictive and descriptive performance of the model Figure S5 and S6. Final pharmacokinetic parameter estimates are presented in Table S4. Individual study participants reported a median of five adverse events Figure 5 b. The number of vaccine-attributable mild, moderate and severe adverse events did not vary significantly between treatment groups Table S6, S7, S8. The participant was diagnosed with dengue fever and recovered without further treatment. Of the volunteers recruited in the study, three participants had a serious adverse event. One participant was diagnosed with acute pharyngitis, one with vestibular migraine and depression, and one with acute sinusitis. None of the serious adverse events were considered to be related to the study vaccine or drugs. This could have been an important operational concern when the vaccine is used in addition to MDA for the acceleration of malaria elimination. It has been observed that the immunogenicity of live, cell-culture rabies vaccines is reduced by co-administration with the antimalarial drug chloroquine which is structurally related to piperaquine and could have immunomodulatory effects that will negatively impact immunological responses to the vaccine. To explore which vaccine dosing schedule would be optimal we compared the immunogenicity of two vaccine doses and formulations, the pediatric dose, the adult dose, and a double pediatric dose. The three antigen and adjuvant doses resulted in comparable antibody titers. Importantly using a higher dose did not result in increased antibody titers or avidity. This finding is of importance for vaccine production which is currently geared to produce pediatric vaccine doses for a large pilot introduction in areas of sub-Saharan Africa. Recent work by Regules and co-workers in human malaria challenge studies found vaccine regimens consisting of two standard vaccine doses with a fractional third dose resulted in better protection against controlled human malaria infection compared with a regimen consisting of three standard doses despite the slightly lower ant-CS response. The fractional dose regimens did not result in higher antibody titers than the three standard dose regimens. The antibody titers measured in Thai volunteers were in the same range as observed in North American volunteers in the earlier study. It was hoped that the use of less resources requiring two-dose vaccine schedule would result in a similar immunogenicity as a three-dose regimen. By month 6 the antibody titers against all three antigens evaluated were lowest in the two-dose regimen. Based on antibody titers alone which may not be sufficient for recommendations in the absence of clinical efficacy data, further exploration of such a 2-dose regimen may not be warranted. Protection against P. Compared to the reference study 20 the absorption of piperaquine in the current study was lower resulting in a relative reduction in bioavailability by However, vaccine dosing i. The co-administration of the vaccine with the antimalarial drugs is therefore unlikely to be the cause of the reduced bioavailability. The most likely explanation is the absence of fat-containing foods with the drug administration. Nearly all participants reported one or more adverse events. Some participants reported 14 and more AEs suggesting a highly variable threshold for reporting AEs is in this population. The most frequently observed attributable adverse events were pain at the injection site and fatigue. Three serious adverse events were observed but none of them was considered to be related to the vaccinations. Hematological and biochemistry parameters were monitored with no attributable abnormalities. While the vaccine was found to be safe in this study, the perception of discomfort could be a deterrent for vaccine uptake in combined mass vaccination and drug administration campaigns. To assure adequate coverage of mass drug and vaccinations campaigns it will be essential to provide credible information to target communities regarding the relative risks and benefits of the campaigns. The absence of a control group receiving placebo prevents the attribution of adverse events to the vaccine or drugs is a limitation of the study. Inclusion of a control group receiving a placebo version of the vaccine and drugs so as to maintain blinding was considered not feasible with the available resources. The study was conducted in unexposed adult Thai volunteers, which leaves the possibility that safety and immunogenicity studies could be different in other Asian populations. A sequence of interventions, universal access to early diagnosis and adequate treatment, vector control for example in the form of improved access to insecticide-impregnated bed nets, three-monthly rounds of combined mass vaccinations and drug administrations MVDA , followed by screening and treatment of imported cases, could eliminate falciparum malaria from low transmission areas in the SE Asia over a period of 3 years. The impact of MVDA will depend on the uptake of the intervention. The clinical development pathway of MVDA will require proof of individual protection in a randomized phase 3 trial in low transmission settings. Such a trial will require thousands of participants even when the planned endpoint is PCR-detected P. Once individual protection has been demonstrated in the target community, community-randomized trials will be needed to assess the impact of this approach on malaria transmission in residents of all ages in high-risk areas. Assuming community-randomised trials demonstrate permanent interruption of transmission on a village level a wider, regional approach will be rolled out which in low-transmission settings is likely to be restricted to communities with evidence of ongoing malaria transmission. In conclusion, MVDA has the potential to interrupt malaria transmission permanently and could play a critical role in the speedy elimination of malaria from low transmission regions. This was a phase 2, open-label, computer-randomized, controlled study in healthy, adult Thai volunteers conducted in the Healthy Volunteer Unit of Mahidol University in Bangkok, Thailand between 6 June and 20 February The following research questions were addressed. Can currently manufactured dosages be deployed? Using this pediatric dose in adults would simplify vaccine procurement for mass vaccination campaigns but the immunogenicity of the pediatric and adult dose has not been compared previously. Could a fractional third dose be used? A vaccine regimen in which two standard doses are followed by a fractional dose consisting of a fifth of a standard dose may be more efficacious than a regimen with three standard doses. To answer these questions a drug — vaccine interaction study was conducted. In addition, we compared the immunogenicity of vaccine regimens with a fifth of the standard third dose with regimens including standard doses only. We compared the tolerability, safety, and immunogenicity of two and three-dose regimens. After reconstitution, 1 dose 0. Participants in treatment groups 4 and 6 received the standard DP treatment on Days 0, 1, 2, on Month 0, 1, 2 and in group 7 on Month 0, 2 Figure S7. In addition, each participant in groups 4, 6, and 7 received a single low dose of primaquine 0. For groups 1 and 2 in which larger differences were anticipated a sample size of 20 participants was thought to be sufficient to document immunogenicity. Whenever possible an attempt was made to replace study participants when a participant was withdrawn or chose to withdraw. After a full explanation of study procedures healthy male or non-pregnant female volunteers, aged 18 to 55 years inclusive , of Thai origin, without a history of malaria, who provided informed consent and were willing to adhere to the study requirements were recruited. Local injection site and general solicited adverse events AEs were monitored on days 2, 3, and 7 post-vaccination and graded as mild, moderate, or severe grades 1, 2, or 3, respectively. All other AEs unsolicited were recorded over a day period after each vaccination. All injection site AEs were considered causally related to vaccination; the causality of all other AEs was assessed by the investigator and these decisions were reviewed by the DSMB and the medical monitor. Hematological and biochemical tests for safety assessment were conducted at screening, on day 0 and 7 of the first vaccination M0 and Month 3. Abnormal test results were followed until they resolved. The immunology assessments used in this trial were described in detail recently. Piperaquine concentrations groups 4 and 6 were assessed during each vaccination round Month 0, 1, and 2 on Day 0, 1, 2, and 7. Primaquine concentrations were assessed during each round 24 h after drug administration. The pharmacokinetic comparison was made at each time point pre-1st dose, pre-2nd dose, pre-3rd dose, and 7 days post-dose using an unpaired Mann-Whitney U-test implemented in Graphpad Prism v7. Piperaquine concentration time data were analyzed using a population pharmacokinetic approach as implemented in the software NONMEM v 7. The main strategy of analysis for the primary outcome analyses immunogenicity was carried out using the intention to treat ITT population including every participant who was randomized. A per-protocol PP analysis including only the study participants who completed the vaccinations and the follow-up schedule was also performed to assess the impact of protocol deviations. The safety outcomes were analyzed using the ITT approach. All participants who received at least one dose of vaccine were included in the safety analyses. Participants lost to follow-up before the completion of the follow-up period assessments were censored on the last day seen. Linear regression was performed on the log values of the protein titers and also on avidity natural scale. P -values less than 0. Written informed consent was obtained from each participant before study procedures were initiated Clinical Trials. We thank the volunteers who kindly agreed to participate in this study. The study was made possible by the dedicated support from the study nurses Somrutai Aurboonkasem, Wasana Saohinkong, Pawinee Khannamkam, and Pawanrat Leungsinsiri. We thank the members of the data safety monitoring board for their support: Prof. Ric Price Casuarina, Australia and the medical monitor, Prof. Elizabeth Ashley Yangon, Myanmar. GlaxoSmithKline Biologicals SA was provided the opportunity to review a preliminary version of this manuscript for factual accuracy, but the authors are solely responsible for final content and interpretation. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Hum Vaccin Immunother. Find articles by Lorenz von Seidlein. Find articles by Borimas Hanboonkunupakarn. Find articles by Podjanee Jittamala. Find articles by Pongphaya Pongsuwan. Find articles by Kesinee Chotivanich. Find articles by Joel Tarning. Find articles by Richard M Hoglund. Find articles by Markus Winterberg. Find articles by Mavuto Mukaka. Find articles by Pimnara Peerawaranun. Find articles by Pasathorn Sirithiranont. Find articles by Zoe Doran. Find articles by Christian F Ockenhouse. Find articles by Karen Ivinson. Find articles by Cynthia Lee. Find articles by Ashley J Birkett. Find articles by David C Kaslow. Find articles by Pratap Singhasivanon. Find articles by Nicholas PJ Day. Find articles by Arjen M Dondorp. Find articles by Nicholas J White. Find articles by Sasithon Pukrittayakamee. Open in a new tab. Baseline characteristics M0 day 0 measurements of the participants by vaccine group. Similar articles. 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