Vaccines against human papilloma viruses.
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Clinical Trials as Topic↗
Biomedical subjects
Taff Jones
Publications and source records attributed to Taff Jones.
Safety and immunogenicity of a Proteosome -trivalent inactivated influenza vaccine, given nasally to healthy adults.
We studied the safety and immunogenicity of a nasally administered vaccine comprising three monovalent inactivated influenza antigens (A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Guangdong/120/2000) non-covalently associated with outer membrane proteins of Neisseria meningitidis (Proteosome) in normal, healthy adults. In a randomized, double-blind trial participants (n = 78) were allocated to placebo or a single nasal dose of vaccine containing 15, 30, or 45 microg of each of the three HA antigens, or two nasal doses containing 30 microg of each HA, separated by 2 weeks. The vaccine was generally well tolerated in all doses tested, and in a one or two-dose schedule. A shallow vaccine reactogenicity dose-response was seen. The most common local reaction was nasal congestion, which occurred in up to 48.3% of vaccine recipients in days 0-6 after vaccine but was mild and self-limiting; this reaction was not significantly more common among active vaccine recipients than placebo recipients. Mild to moderate headache was the most commonly reported systemic reactogenicity complaint in all treatment groups, and was the only solicited complaint to increase significantly in frequency after a second active dose. No severe systemic reactions occurred. A positive and statistically significant antibody response was observed, in serum and in nasal secretions, to increasing dose for all three antigens. Serum HAI titre responses and nasal secretory IgA immune responses were elicited against all three antigens. Further testing of this nasal influenza vaccine is warranted to determine its safety and immunogenicity in these populations and its efficacy in the prevention of clinical illness.
Administration, Intranasal↗
Intranasal Protollin/F1-V vaccine elicits respiratory and serum antibody responses and protects mice against lethal aerosolized plague infection.
F1-V is a recombinant plague antigen comprising the capsular (F1) and virulence-associated (V) proteins. Given intramuscularly with Alhydrogel, it protects mice against challenge, but is less effective in non-human primates against high-dose aerosolized Yersinia pestis challenge, perhaps because it fails to induce respiratory immunity. Intranasal immunization of mice with F1-V formulated with a Proteosome-based adjuvant (Protollin), elicited high titers of specific IgA in lungs whereas intranasal F1-V alone or intramuscular Alhydrogel-adsorbed F1-V did not. The Protollin-adjuvanted F1-V vaccine also induced high serum titers of specific IgG, comparable to those induced by intramuscular Alhydrogel-adsorbed F1-V. Mice immunized intranasally with Protollin-F1-V were 100% protected against aerosol challenge with 170 LD50 of Y. pestis and 80% against 255 LD50.
Administration, Intranasal↗
Boostrix (GlaxoSmithKline).
GlaxoSmithKline plc has developed and launched Boostrix, a subunit vaccine for use in adolescents and adults as a booster immunization against diphtheria, tetanus and pertussis (DTPa) infections.
Adolescent↗
Protollin: a novel adjuvant for intranasal vaccines.
Protollin is a novel adjuvant comprising Proteosomes non-covalently complexed with LPS. Intranasal immunization of mice with Protollin combined with detergent-split influenza antigens (HA) or recombinant influenza hemagglutinin (rHA) enhanced serum IgG and mucosal IgA levels by up to 250-fold compared with immunization with the antigens alone. IFN-gamma responses were also enhanced compared to the levels produced by splenocytes from mice immunized with antigen alone, while production of IL-5 was abrogated. Mice immunized with Protollin-rHA were completely protected against lethal challenge with influenza virus, demonstrating that Protollin is an effective mucosal adjuvant for prophylactic vaccines.
Adjuvants, Immunologic↗
A chimeric live attenuated vaccine against Japanese encephalitis.
Japanese encephalitis is a disease of the CNS, endemic in Asia and Oceania. The disease is refractory to drug treatments and whilst the rural economies remain heavily dependent on agriculture, conditions for propagation of the disease will persist. Thus, there is a need for effective vaccines. Although some currently exist, they have their shortcomings. ChimeriVax-JE (Acambis Inc.) is a chimeric, live attenuated vaccine which expresses protective Japanese encephalitis antigens and to date has proven to be safe, effective and well-tolerated in clinical trials. It therefore appears to be a cost-effective prophylactic vaccine against this debilitating disease.
Cost-Benefit Analysis↗
Vaccines to remember: managing health in our twilight years.
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Age Factors↗
Technology evaluation: ChimeriVax-DEN, Acambis/Aventis.
Acambis, in collaboration with Aventis Pasteur, is developing a chimeric vaccine based on a recombinant yellow fever vaccine for the potential prevention of dengue virus infection. The vaccine is undergoing phase I clinical trials.
Animals↗
Peru-1 5 (AVANT).
Peru-15 is a single dose, recombinant cholera vaccine under development by AVANT Immunotherapeutics for the potential prevention of cholera. A phase II trial of Peru-15 was ongoing in June 2003, and as of September 2003 AVANT was planning a phase III trial in a developing country, and phase IIb and phase III challenge studies in travelers.
Chemistry, Pharmaceutical↗
A nasal Proteosome influenza vaccine containing baculovirus-derived hemagglutinin induces protective mucosal and systemic immunity.
The potential for enhancing the immunogenicity of recombinant (baculovirus-derived) influenza hemagglutinin (rHA) was investigated by comparing the immune responses elicited in mice by an intranasal (i.n.) rHA formulated with Proteosomes, with those induced by intramuscular (i.m.) or i.n. rHA alone. The Proteosome-rHA vaccine induced mucosal responses in the respiratory tract, as well as high serum IgG and hemagglutination inhibition (HAI) titers. In contrast, rHA alone given i.m. induced serum IgG without mucosal responses and was ineffective at inducing either mucosal or systemic responses when given i.n. Only mice immunized with the Proteosome-rHA vaccine were completely protected from both death and acute morbidity following live virus challenge, indicating that the i.n. Proteosome-rHA vaccine induced more complete protective immunity than the same doses of unformulated rHA given i.n. or i.m.
Adjuvants, Immunologic↗
Resiquimod 3M.
3M Pharmaceuticals is developing a topical formulation of resiquimod as an immunomodulator for the potential treatment of herpes simplex virus (HSV) infections. As of September 2001, resiquimod was to be commercialized worldwide in association with Eli Lilly. Phase III trials for the treatment of HSV infection were initiated in November 2000 and were ongoing in September 2001. In October 2001, US and European filings were scheduled for 2004, and by February 2002, Lilly was anticipating launch in either 2004 or 2005. The compound has also been investigated for the potential treatment of various other diseases, including other viral infections and eczema and as a vaccine adjuvant.
Administration, Topical↗
ChimeriVax-JE. Acambis.
Acambis (formerly Peptide Therapeutics Group) is developing a vaccine for the potential prophylaxis of Japanese encephalitis (JE) virus infections. In August 2001, Acambis commenced a phase II trial of its ChimeriVax-JE vaccine; these studies were complete by February 2002 and the company was making plans to begin an additional phase II study in children living in areas where JE is prevalent. By May 2003, Acambis had initiated a phase II trial in Australia.
Animals↗
StaphVAX (Nabi).
StaphVAX is a bivalent polysaccharide- and protein-conjugated vaccine, directed against capsular Staphylococcus aureus types 5 and 8, which are associated with 80 to 90% of S aureus clinical infections. The vaccine is being developed by Nabifor the potential treatment of infections in kidney patients who are receiving peritoneal dialysis and are prone to serious staphylococcal infections [193495], [221403], [222643], [283114]. In February 2001, Nabi revealed that it was movingforward during the second quarter of 2001 with previously stated plans to conduct a boosting study of StaphVAX in patients with end-stage renal disease (ESRD). This study would be conducted in patients who were enrolled in the first phase III trial and the company expected completion by early 2002 [283114]. The company was also progressing with scale-up of the manufacturing process for commercial production of the vaccine. Nabi met with the FDA in December 2000 to review results from its phase III trial of StaphVAX in patients with ESRD. The FDA stated that a definitive demonstration of preventative efficacy in another well-designed, randomized and controlled clinical study would be required for licensing. At this time, Nabi was making plans for this second phase III trial, despite plans to appeal the FDA's decision [397729].
Clinical Trials as Topic↗
Varivax (Merck & Co).
Varivax is a live-attenuated varicella vaccine developed and launched in the US by Merck & Co for the treatment of chickenpox [413319]. The vaccine uses the Oka strain of the varicella virus licensed from the Biken Institute at Osaka University in Japan [178223]. By June 2001, Merck was also developing the vaccine for use in adults for herpes zoster infection [413319]. The FDA required post-marketing studies as a condition for its approval of Varivax, which was granted in March 1995 [174416]. The Centers for Disease Control & Prevention Advisory Committee on Immunization Practices recommended that Varivax should be administered at the same time as the measles, mumps and rubella vaccine. Unvaccinated children between the ages of 19 months and 13 years should be vaccinated by the time they are 13 years old [180148]. Varivax, from its launch in the spring of 1995 to the end of the third quarter 1995, produced sales of US $60 million [196542]. In June 2000, a second generation of Varivax, Varivax II, was launched for vaccination against chickenpox in individuals 12 months of age and older. Varivax II prevents the transmission of chickenpox with exactly the same safety and efficacy profile as Varivax; however, the new Varivax II has the advantage of being refrigerator-stable [371871].
Chickenpox↗
Remune. Immune Response.
The Immune Response Corp (IRC) is developing Remune, a potential HIV therapeutic vaccine. Remune is based on the Salk Immunogen, which is derived from an HIV isolate which has been inactivated by chemical depletion of glycoprotein 120 (gp120). Preliminary data suggested that Remune, in combination with antiviral drug therapy, results in undetectable levels of HIV. Phase III trials commenced in May 1997 and it was initially expected that registration filings would be made in 1999. However, following interim analysis of the 2500-patient, multicenter, double-blind, pivotal phase III study (study 806) in May 1999, an independent panel recommended concluding the clinical endpoint trial and IRC and licensee, Agouron, decided to pursue alternative regulatory strategies, including initiating two additional phase III surrogate marker trials. Despite this, Agouron gave IRC notice of termination of its continued development in July 2001. In August 2001, IRC informed Agouron that, due to the total number of endpoints to date falling short of that previously assumed by Agouron, it did not intend to continue Agouron's Study 202 of Remune. In July 2001, licensee Trinity Medical Group filed an NDA with the governing health authorities in Thailand for Remune. The Thai FDA certified Immune Response's Remune manufacturing facility as being in compliance with GMP standards, following an on site inspection by Thai officials in November 2001 that was performed as a requirement of Trinity's Thai NDA. As a result of this certification, Trinity expected that a "timely determination" could be made by the Thai FDA. Rhĵne-Poulenc Rorer discontinued its part in the development of Remune, with all manufacturing, marketing and distribution rights reverting to IRC. After Agouron returned rights to Remune in July 2001, IRC heldfull rights in the US, Europe and Japan, while collaborating with its partners Trinity Medical Group and Roemmers Laboratory in the Southeast Asian and Latin American markets, respectively. In June 1998, Merrill Lynch had expected an FDA filing for Remune by the end of 1999, and in May 1999 Agouron was hoping to file an NDA for the use of Remune against AIDS during 2001. Analysts at Lehman Brothers predicted in September 2001, that the product would be launched onto the market with sales of US$150 million in 2004.
AIDS Vaccines↗
Hepagene (PowderJect).
Celltech Group (formerly Medeva) developed Hepagene, a recombinant polyvalent vaccine with potential activity against hepatitis B virus infections [353474]. In September 2000, PowderJect acquired the product as part of its acquisition of Celltech's vaccine manufacturing business [381557]. In July 2001, PowderJect reported that evaluation was nearing completion. At this time, the company expected to launch the vaccine in the coming months [443490]. Hepagene is a polyvalent vaccine with S, pre-S1 and pre-S2 hepatitis B epitopes forming the basis of its antigenicity. Additionally, these surface markers have been glycosylated in order to resemble the live virus more closely [254780]. By June 2000, Celltech and PowderJect were evaluating Hepagene, utilizing PowderJect's needle-less injection technology [379536]. In December 1999, Lehman Brothers predicted that the product had a 50% chance of reaching the treatment (rather than prevention) market, with potential peak sales of US $600 million [352078].
Animals↗