Safety, tolerability, and lack of antibody responses after administration of a PfCSP DNA malaria vaccine via needle or needle-free jet injection, and comparison of intramuscular and combination intramuscular/intradermal routes

Human Gene Therapy

Volumn 13, Issue 13, 2002, Pages 1551-1560

  Epstein, Judith E ^a   Gorak, Edward J ^b,e   Charoenvit, Yupin ^a   Wang, Ruobing ^a   Freydberg, Nicole ^a   Osinowo, Oluwatoyin ^b   Richie, Thomas L ^a   Stoltz, Erin L ^a   Trespalacios, Fernando ^b,e   Nerges, John ^b   Ng, Jennifer ^a,b   Fallarme Majam, Victoria ^a   Abot, Esteban ^a   Goh, Lucy ^a,f   Parker, Suezanne ^c   Kumar, Sanjai ^a,g   Hedstrom, Richard C ^a,h   Norman, Jon ^c   Stout, Richard ^d   Hoffman, Stephen L ^a,i  

^a NAVAL MEDICAL RESEARCH CENTER   (United States)

^b UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

^c VICAL INC   (United States)

^d Bioject Inc   (United States)

^e WALTER REED ARMY MEDICAL CENTER   (United States)

^f Pediatric Specialty Center   (United States)

^g CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^h DynPort Vaccine Company LLC   (United States)

ⁱ SANARIA INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DNA ANTIBODY; DNA VACCINE; GAMMA INTERFERON; MALARIA VACCINE;

ADULT; ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOFLUORESCENCE TEST; IMMUNOGENICITY; JET INJECTION; MALAISE; MALE; MYALGIA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VERTIGO;

ANIMALS; HUMANS; INJECTIONS, INTRADERMAL; INJECTIONS, INTRAMUSCULAR; MALARIA; PLASMODIUM FALCIPARUM; VACCINES, DNA;

ANIMALIA; PLASMODIUM FALCIPARUM;

EID: 0036377874     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/10430340260201644     Document Type: Article

References (57)

1. Enhancement of the immune response in rabbits to a malaria DNA vaccine by immunization with a needle-free jet device
2. Vaccination of seronegative volunteers with a human immunodeficiency virus type 1 env/rev DNA vaccine induces antigen-specific proliferation and lymphocyte production ofb β-chemokines
3. Immune responses in asymptomatic HIV-1-infected patients after HIV-DNA immunization followed by highly active antiretroviral treatment
4. Gene combination raises broad human immunodeficiency virus-specific cytotoxicity
5. Hepatitis B associated with jet gun injection - California
6. Characterization of Plasmodium yoelii monoclonal antibodies directed against stage-specific sporozoite antigens
7. Development of two monoclonal antibodies against Plasmodium falciparum sporozoite surface protein 2 and mapping of the B cell epitopes
8. The complexity of protective immunity against liver-stage malaria
9. Tissue reaction to jet injection
10. Injection safety in immunization programmes
11. Enhanced CD8 T cell immunogenicity and protective efficacy in a mouse malaria model using a recombinant adenoviral vaccine in heterologous prime-boost immunisation regimes
12. Malaria DNA vaccines in Aotus monkeys
13. Effective induction of HIV-specific CTL by multi-epitope using gene gun in a combined vaccination regime
14. In vitro expression and in vivo immunogenicity of Plasmodium falciparum pre-erythrocytic stage DNA vaccines
15. Potentiation of simian immunodeficiency virus (SIV)-specific CD4(+) and CD8(+) T cell responses by a DNA-SIV and NYVAC-SIV prime/boost regimen
16. Research (genomics) is crucial to attacking malaria
17. Administration of Hepatitis A vaccine to a military population by needle and jet injector and with hepatitis B vaccine
18. Cancer gene therapy using plasmid DNA: Purification of DNA for human clinical trials
19. Enhancing efficacy of recombinant anticancer vaccines with prime/boost regimens that uses two different vectors
20. Protection of Aotus monkeys by Plasmodium falciparum EBA-175 region II DNA prime-protein boost immunization regimen
21. Enhanced T-cell immunogenicity and protective efficacy of a human immunodeficiency virus type 1 vaccine regimen consisting of consecutive priming with DNA and boosting with recombinant fowlpox virus
22. Two-step chromatographic purification of recombinant Plasmodium falciparum circumsporozoite protein from Escherichia coli
23. Safety, tolerability, and humoral immune responses after intramuscular administration of a malaria DNA vaccine to healthy adult volunteers
24. Potent, protective anti-HIV immune responses generated by bimodal HIV envelope DNA plus protein vaccination
25. An ospA-based DNA vaccine protects mice against infection with Borrelia burgdorferi
26. First human trial of a DNA-based vaccine for treatment of Human Immunodeficiency Virus Type I infection: Safety and host response
27. Safety and immune responses to a DNA-based Human Immunodeficiency Virus (HIV) Type I env/rev vaccine in HIV-infected recipients: Follow-up data
28. Plasmid DNA malaria vaccine: The potential for genomic integration following intramuscular injection
29. Naked DNA and adenoviral immunizations for immunotherapy of prostate cancer: A Phase I/II clinical trial
30. Evaluation of the Biojector Injection Management System for healthcare worker acceptance and patient tolerance
31. Do DNA vaccines induce autoimmune disease?
32. Codon optimization of gene fragments encoding Plasmodium falciparum merozoite proteins enhances DNA vaccine protein expression and immunogenicity in mice
33. Large-scale oligonucleotide typing for HLA-DRB1/3/4 and HLA-DQB1 is highly accurate, specific, and reliable
34. Large-scale DRB and DQB1 oligonucleotide typing for the NMDP registry: Progress report from year 2
35. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule®): Comparison with standard syringe injection
36. Plasmid DNA malaria vaccine: Tissue distribution and safety studies in mice and rabbits
37. Safety of a GM-CSF adjuvant-plasmid DNA malaria vaccine
38. Protection from Plasmodium berghei infection by priming and boosting T cells to a single class I-restricted epitope with recombinant carriers suitable for human use
39. Does a needleless injection system reduce anxiety in children receiving intramuscular injections?
40. Taking the sting out of shots: Control of vaccination-associated pain and adverse reactions
41. Neutralizing antibody-independent containment of immunodeficiency virus challenges by DNA priming and recombinant pox virus booster immunizations
42. Protection of Rhesus macaques against lethal P. knowlesi malaria by a heterologous DNA priming and poxvirus boosting immunization regimen
43. Induction of antigen-specific CD8+ T cells, T helper cells, and protective levels of antibody in humans by particle-mediated administration of a hepatitis B virus DNA vaccine
44. The malaria burden and Africa
45. Enhanced immunogenicity for CD8+ T cell induction and complete protective efficacy of malaria DNA vaccination by boosting with modified vaccinia virus Ankara
46. Protection against malaria by immunization with plasmid DNA encoding circumsporozoite protein
47. Boosting with recombinant vaccinia increases immunogenicity and protective efficacy of malaria DNA vaccine
48. Phase I safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by gene delivery device
49. Range of antinuclear antibodies in "healthy" individuals
50. Genetic immunization is a simple method for eliciting an immune response
51. Heterologous protection against influenza by injection of DNA encoding a viral protein
52. Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine
53. (+) type 1 responses in humans by a malaria DNA vaccine
54. Phase I clinical trial with HIV-1 gp160 plasmid vaccine in HIV-1-infected asymptomatic subjects
55. Hepatitis A vaccine administration: Comparison between jet-injector and needle injection
56. Risk for virus transmission by jet injection