Phase I Trial of ICC-1132, a Candidate Vaccine Against Plasmodium Falciparum Malaria Based on a Viral-like Particle Comprising Recombinant Hepatitis B Core Antigen and Circumsporozoite Epitopes, to Assess Vaccine Safety and Immunogenicity in Healthy Adult Volunteers

The purposes of this study are to evaluate the safety and immune responses (the body's defense system) to an investigational malaria vaccine called ICC-1132. Three different doses of the vaccine will be studied in 3 groups of people, and the results will be compared. The study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood samples will be collected approximately 15 times for laboratory studies. Volunteers will record their temperature twice per day. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Volunteers will participate in the study for up to 13 months.

Start Date01 Jul 2002

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Malaria vaccine(Path Malaria Vaccine Initiative)

100 Translational Medicine associated with Malaria vaccine(Path Malaria Vaccine Initiative)

100 Patents (Medical) associated with Malaria vaccine(Path Malaria Vaccine Initiative)

Literatures (Medical) associated with Malaria vaccine(Path Malaria Vaccine Initiative)

01 Oct 2024·LANCET INFECTIOUS DISEASES

The effect of Plasmodium falciparum exposure and maternal anti-circumsporozoite protein antibodies on responses to RTS,S/AS01E vaccination in infants and children: an ancillary observational immunological study to a phase 3, randomised clinical trial

Article

Author: Kusi, Kwadwo Asamoah ; Moncunill, Gemma ; Macià, Dídac ; Dobaño, Carlota ; Mpina, Maximilian ; Kariuki, Simon ; Sorgho, Hermann ; Campo, Joseph J ; Jairoce, Chenjerai ; Mordmüller, Benjamin ; Molinos-Albert, Luis M ; Dosoo, David ; Daubenberger, Claudia ; Agnandji, Selidji Todagbe

BACKGROUND:

The RTS,S/AS01_E malaria vaccine showed lower antibody response and protective efficacy in infants aged 6-12 weeks compared with children aged 5-17 months (for whom this vaccine is recommended). We aimed to study the effect of previous Plasmodium falciparum exposure on the antibody responses to RTS,S/AS01_E vaccination in infants and children, and the mediating effect of baseline (including maternal) anti-circumsporozoite protein (CSP) antibodies.

METHODS:

In this observational study, we included children and infants from six African countries (Burkina Faso, Gabon, Ghana, Kenya, Mozambique, and Tanzania) enrolled in the MAL067 immunology ancillary study of the RTS,S/AS01_E phase 3 clinical trial from March 27, 2009, to Jan 21, 2011. We used comparator-vaccinated infants and children to identify antibody-based signatures of previous P falciparum exposure, which were later applied to RTS,S/AS01_E-vaccinated infants and children. In these participants, we explored the relationship between vaccine antibody immunoglobulin G (IgG) responses measured by ELISA and pre-vaccination serological markers of malaria exposure by assessing the IgG levels against 1000 P falciparum antigens using partial proteome microarrays.

FINDINGS:

We included 718 comparator-vaccinated infants (348 [48%]) and children (370 [52%]) and 606 RTS,S/AS01_E-vaccinated infants (329 [54%]) and children (277 [46%]). Anti-CSP IgG responses to primary vaccination did not correlate with a baseline signature of previous exposure in children, suggesting that prior P falciparum exposure does not significantly affect antibody immunogenicity in children (Pearson's r=-0·02 [95% CI -0·13 to 0·10]). By contrast, high P falciparum exposure signature levels at the time of vaccination in infants, presumably driven by maternally transferred antibodies and declining within the initial 6-12 months of life, correlated with reduced RTS,S/AS01_E responses (r=-0·17 [-0·27 to -0·06]). This negative correlation was stronger for anti-CSP IgG than for the exposure signature or any other more immunogenic blood stage P falciparum antigens (r=-0·42 [-0·50 to -0·33]), persisted after adjustment by baseline levels of the exposure signature (semi-partial correlation r=-0·44 [-0·55 to -0·33]), and involved antibodies to the central NANP region (r=-0·39 [-0·49 to -0·28]) but not the C-terminal region (r=0·02 [-0·10 to 0·15]) of CSP. The negative effect of maternal anti-CSP IgG in infants did not appear to be confounded by other malaria transmission-dependent variables.

INTERPRETATION:

Interference between passive immunity and vaccine response is clinically significant and might affect the implementation of next-generation CSP-based vaccines for young infants and mothers as well as passive immunisation with human monoclonal antibodies.

FUNDING:

US National Institutes of Health, National Institute of Allergy and Infectious Diseases; PATH-Malaria Vaccine Initiative; Spanish Ministerio de Economía y Competitividad (Instituto de Salud Carlos III), European Regional Development Fund and European Social Fund; Fundación Ramón Areces; Spanish Ministry of Science and Innovation; and Generalitat de Catalunya (CERCA Program).

01 Nov 2013·Lancet (London, England)Q1 · MEDICINE

Management of small gastrointestinal stromal tumours

Q1 · MEDICINE

Letter

Author: Fujita, Tetsuji

1 Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet 2013; 382: 973–83. 2 National Comprehensive Cancer Network. Clinical practice guidelines in oncology: soft tissue sarcoma (version 1.2013) https:// subscriptions.nccn.org/gl_login. aspx?ReturnURL=http://www.nccn.org/ professionals/physician_gls/pdf/sarcoma.pdf (accessed Sept 20, 2013). 3 Demetri GD, von Mehren M, Antonescu CR, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw 2010; 8: S1–41. 4 Pisters PWT, Patel SR. Gastrointestinal stromal tumors: current management. J Surg Oncol 2010; 102: 530–38. 5 Saracco GM, Rizzetto M, De Angelis C. The natural history of gastrointestinal subepithelial tumors arising from muscularis propria: an endoscopic ultrasound survey. J Clin Gastroenterol 2009; 43: 821–25. 1 Kleinschmidt I, Schwabe C, Benavente L, et al. Marked increase in child survival after four years of intensive malaria control. Am J Trop Med Hyg 2009; 80: 882–88. 2 WHO. World Malaria Report. 2012. http:// www.who.int/malaria/publications/world_ malaria_report_2012/en/index.html (accessed Oct 11, 2013). 3 WHO. Strategic Advisory Group of Experts on Immunization. 2013. http://www.who.int/ immunization/sage/en/ (accessed Oct 11, 2013). 4 WHO. Malaria Policy Advisory Committee. 2013. http://www.who.int/malaria/mpac/en/ (accessed Oct 11, 2013). 5 PATH-malaria vaccine Initiative. RTS,S malaria vaccine candidate. http://www.malariavaccine. org/rd-rtss.php (accessed Oct 11, 2013).

01 May 2008·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Author: Moral, M A ; Tomillero, A

11D10, 9vPnC-MnCc; Adalimumab, Adefovir dipivoxil, Alefacept, ALN-RSV01, AME-133, AMG-317, Aminolevulinic acid methyl ester, Amlodipine besylate/atorvastatin calcium, Anisodamine, Anti-IL-5 receptor antibody, Apremilast, Aripiprazole, Atacicept, Atazanavir sulfate, Atrasentan; Banoxantrone, Bevacizumab, BIBW-2992, Binodenoson, BMS-387032; cAC10, Caldaret hydrate, CD-NP, Ceftobiprole medocaril, Celivarone fumarate, Certolizumab pegol, Cholesteryl hydrophobized polysaccharide-Her2 protein complex, Choline fenofibrate, Cilengitide, Cinaciguat, Curcumin, Custirsen sodium, Cypher, CYT-6091; Dalcetrapib, Deforolimus, Desvenlafaxine succinate, DHA-paclitaxel, DP6-001; E-7010, E75, Ecogramostim, EGF-P64K, EnvPro, Enzastaurin hydrochloride, Escitalopram oxalate, Ezetimibe, Ezetimibe/simvastatin; Fenretinide; Gefitinib, Golimumab, Green tea catechins, GTI-2040, GW-406381; HPV16 E6 E7, HPV-16/18 AS04, HPV-6/11/16/18; ICC-1132, Immune globulin intravenous (human), Indacaterol, Intranasal insulin; Kahalalide F; Lactobacillus rhamnosus, Laromustine, Laropiprant, GTI-2040; MAb 3H1, Mepolizumab, Mifamurtide, Milataxel, MP4; Nebicapone, Nelarabine, Neuradiab; Oncolytic HSV; PCV7, PHX-1149, Pimecrolimus, Pralatrexate, Pramiconazole; Ranibizumab, Reolysin, Rilonacept, Rolofylline, Romidepsin; S-32865, Shigella dysenteriae 1 vaccine; Taranabant, Taxus, TZP-101; Ustekinumab; Vitespen; Zileuton, Zycure.

100 Deals associated with Malaria vaccine(Path Malaria Vaccine Initiative)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Malaria	Phase 2	-	Path Malaria Vaccine Initiative	-
Malaria	Phase 2	-	Apovia AG	-
Hepatitis B	Phase 1	US	National Institute of Allergy & Infectious Diseases	01 Jul 2002
Malaria, Falciparum	Phase 1	US	National Institute of Allergy & Infectious Diseases	01 Jul 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Malaria vaccine(Path Malaria Vaccine Initiative)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation